PII: S0003-4878(99)00024-1

Ann. occup. Hyg., Vol. 43, No. 4, pp. 275281, 1999

# 1999 British Occupational Hygiene Society
Published by Elsevier Science Ltd. All rights reserved
00034878/99/$20.00 + 0.00

Evaluation of the Quality of Surgical Gloves Among

Four Dierent Manufactures
K.-L. HWANG,*$ S.-J. KOU,* Y.-M. LU* and N.-C. YANG$
*Changhua Christian Hospital, 135 Nan Siau Street, 14F, Changhua 500, Taiwan; $Department of
Toxicology, Veterans General Hospital, Taichung, Taiwan

Keywords: surgical gloves; quality evaluation; latex allergy; perforation; Taiwan

INTRODUCTION

With the increase in the use of rubber gloves, allergic reactions to latex have been reported more and
more frequently since the rst described case in 1979
(Nutter, 1979). High risk groups who are hypersensitive to latex proteins include not only the health
personnel in operating rooms, but also the patients
with certain conditions, such as children with spina
bida and patients who have undergone multiple
surgical procedures (Moneret-Vautrin et al., 1993;
Kelly et al., 1994; Woods et al., 1997). Other risk
groups have also been reported to include persons
with atopy, patients with congenital urinary tract
anomalies, individuals with chronic exposure to
rubber products, and patients with cross-sensitization (Moneret-Vautrin et al., 1993; Charous et al.,
Received 19 October 1998; in nal form 6 February 1999.
$Author to whom correspondence should be addressed.
Tel.: +886-4-723-8595; Fax: +886-4-723-6932.
275

1994; Slater, 1994; Weido and Sim, 1995). It was

observed that the prevalence of symptomatic or skin
test conrmed latex allergy among health care
workers ranged from 2.9% to 41%, with the highest
rate being found among operating room personnel
(Turjanmaa, 1987; Lagier et al., 1992; Sussman and
Beezhold, 1995). Recent studies also indicated that
dental practitioners and laboratory workers were
both high risk groups for latex sensitivity with
prevalence rates of 24% and 17%, respectively
(Amin et al., 1996; Liss et al., 1997). The most common adverse reaction to latex is an allergic contact
dermatitis, a delayed hypersensitivity reaction to
rubber additives. Other signs and symptoms upon
exposure to latex include urticaria, rhinoconjunctivitis, sinusitis, wheezing, asthma, and anaphylaxis
(Tarlo et al., 1990; Sussman and Beezhold, 1995;
Woods et al., 1997). For patients with mucosal or
visceral exposure to surgical gloves, severe or even
fatal anaphylaxis may occur to those who are hypersensitive to the latex proteins, and this is often mis-

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A randomized trial was conducted to evaluate the quality of four dierent brands of surgical
gloves in terms of the perforation rate, ventilation, tness, allergic reaction, elasticity,
thickness, powder, and satisfaction. Gloves of four dierent manufactures which were used by
various medical centres were distributed to participants according to a computer-generated
randomization table. A structured questionnaire was self-administered by volunteers
immediately after the surgical procedure to gather the information from participants, including
the demographic data, allergy history, length of use, and variables of quality measures. Two
brands, A and D, were signicantly inferior to the best manufacture among the four, B, in
terms of the ventilation, elasticity, and thickness, odds ratios ranging from 6 to 24, p < 0.05.
For the amount of corn starch powder and satisfaction, all three other brands were inferior to
brand B, odds ratios ranging from 6 to 44, p < 0.05. Gloves worn longer than 2 hours had a
slightly higher perforation rate post procedures (11.5% vs. 2.1%, p=0.048). The rate of latex
allergic reaction was not signicantly dierent between surgeons (8.3%) and the others (6.7%).
No dierence of the allergic reaction rate was found between subjects with allergy history
(7.7%) and those without the history (7.5%). The quality of surgical gloves diers from brand
to brand. The government and institutions should take the responsibility of monitoring the
quality of surgical gloves in order to provide a safer and more comfortable environment for the
surgical personnel and patients. # 1999 British Occupational Hygiene Society. Published by
Elsevier Science Ltd. All rights reserved.

276

K.-L. Hwang et al.

MATERIAL AND METHODS

Data collection
Between May 1, 1998 and May 20, 1998, 66
health care professionals, 32 (48.5%) males and 34
(51.5%) females, who routinely wore rubber gloves
in operating rooms voluntarily participated in this
glove evaluation trial, including 35 physicians, 30
nurses and one technician. Gloves were labelled
with A, B, C, and D, respectively for four dierent
brands, and were distributed to the participants
according to a randomization table generated by
computer. However, it was not possible to achieve
blinding due to the manufacture mark on the plastic
bags of gloves. A standardized structured questionnaire was self-administered by volunteers immediately after the procedure. Each individual was asked
to try wearing two pairs of each of the four brands.

Variables studied
We used the self-administered questionnaire to
collect variables of interests, including the demographic information, allergic history, variables of
glove quality (i.e., perforation, ventilation, tness,
allergic reaction, elasticity, thickness, powder, and
satisfaction), and the type and length of procedure.
A sample of the questionnaire is provided in
Appendix A. The glove perforation on both hands,
including the number of pinholes, was visually
examined by participants before and after the surgical procedure. The reason for the perforation, the
frequency of electric shock punctures (during electrocautery) due to the glove defect, the occurrence
and types of symptoms of adverse reactions to the
trial gloves, and the frequency and reasons for changing gloves during a procedure were also recorded
by participants. Other quality measure scores were
decided by individuals' judgement.

Statistical analysis
Frequencies of defect gloves, allergy events, and
other binary measures for quality of the four dierent brands were compared by using a chi-square test
or Fisher's exact test when appropriate. We also
compared the quality measures between the gloves
worn for less than or equal to two hours and those
worn for longer than two hours. Analysis of variance (ANOVA) and Schee's multiple comparison
procedure were performed on continuous variables.
Since there were volunteers who tested more than
one glove, the generalized estimating equation
(GEE) was used to adjust the autocorrelation
among observations from the same individuals for
multiple regression analysis. Odds ratios and 95%
condence intervals were calculated for all quality
measures with brand B as the reference group.

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diagnosed as drug allergy (Korniewicz and Kelly,

1995).
Since latex gloves provide barrier protection to
both patients and health workers against exchanging
microorganisms through their hands and body uid,
the Food and Drug Administration (FDA) standards in the United States require that manufactures
of surgical gloves provide basic quality control for
glove tears, holes, or other defects (i.e., 25 per 1,000
gloves are allowed to have defects) (US FDA, 1991).
Studies performed on personnel in operating room
and dental procedures indicated high glove leak
rates after the medical procedures (858%) (Albin et
al., 1992; Avery et al., 1998; Newsom et al., 1998).
The highest perforation rates were observed among
surgeons and assistants in some studies (Albin et al.,
1992; Greco and Garza, 1995), while scrub nurses
were the major risk group in others (Chapman and
Du, 1993; Wong et al., 1993). The thumb and
index nger of the non-dominant hand accounted
for most of the defects (Serrano et al., 1991; Albin
et al., 1992; Miller and Apt, 1993). More than 60%
of the perforations were unrecognized either during
the time or at the end of the operation (Serrano et
al., 1991; Hansen et al., 1992; Wong et al., 1993).
The length of use was also found positively associated with the frequency of glove perforations
(Hansen et al., 1992; Miller and Apt, 1993; Greco
and Garza, 1995).
Although the problems of latex hypersensitivity
and quality control of surgical gloves have been
monitored and regulated by the governments of
many countries, they are little noticed by either the
medical sta or the public in Taiwan. Our hospital
administrator observed an increase in complaints of
adverse reactions and punctures to the surgical
gloves since the previous brand had been adopted.
The primary objective of this study was to investigate the variation in the quality of surgical gloves
among four dierent manufactures currently being
used by various medical centres in Taiwan, and to
provide the resulting information for the hospital to
choose the proper gloves for employees. Secondly,
the prevalence and symptoms of adverse reactions
to these trial gloves were also addressed in the
study. To ensure that our medical workers are in a
safe and comfortable working environment to have
the best quality of performance, we focused not
only on perforation and hypersensitive reactions,
which had previously been discussed in the literature, but also on other glove features such as ventilation, tness, allergic reaction, elasticity, thickness,
powder, and personal satisfaction. Whether or not
the participant would suggest a specic manufacture
was considered as an overall evaluation outcome for
the trial gloves.

Evaluation of the quality of surgical gloves among four dierent manufacturers

RESULTS

frequency of 7 and 5, respectively, and one respiratory symptom was reported.

Results of the quality measures are summarized in
Fig. 1. Brand B was favoured in terms of the allergic
reactions, ventilation, elasticity, thickness, powder,
and satisfaction, while brands A and D had poor
evaluation results, p < 0.05. More than half of the
responders suggested that the hospital should not
purchase either brand A (54%) or D (55%) after the
test trial, and the proportions against using brand B
and C were 12% and 30%, respectively, p<0.05.
Since brand B was superior to the rest of the
tested brands, we compared the other three brands
to brand B by using the GEE model to adjust the
collinearity of repeated measurement and the gloves
wearing-time. Table 3 presents odds ratios (OR) and
95% condence intervals of all variables with brand
B as reference. Brand A was signicantly inferior to
brand B for all evaluation variables except tness,
odds ratios ranging from 5.9 to 43.5, p<0.05. Brand
D had signicantly inferior ventilation, elasticity,
thickness, amount of powder, and satisfaction compared to brand B (OR's: 10.526.1, p<0.05). Brand
C was comparable to brand B except the amount of
corn starch powder (OR=11.6, p < 0.05) and satisfaction (OR=6, p < 0.05). In terms of whether or
not the participants would recommend the tested
gloves, people were about 7 times more likely to
object to further purchase of the brands A and D
than B, p<0.05.
DISCUSSION

The reason for unequal group sizes was because

of the insucient manufacturer supplies of proper
glove sizes for voluntary participants. Although the
defect rate of unused gloves among the 198 tested
gloves, 0, was below the requirement of the FDA
standards, 2.5%, it was very likely underestimated,
as the waterleak test was not performed. The
observed perforation rate post surgical procedures,
3.5% (7/198) implied an actual rate within 935%
when the proportion of unrecognized pinholes was
assumed to be 6090% (Serrano et al., 1991;
Hansen et al., 1992; Wong et al., 1993), which was
comparable to results from other studies of various

Table 1. Allergy history of 12 atopic participants

Number
Allergen

Allergy history

Seafood
Penicillin
Dust/pollen
Animal hair
Glove powder
Asthma
Allergic rhinitis
Hay fever
To specic food

1
1
7
2
1
1
4
1
1

%
8.3
8.3
58.3
16.7
8.3
8.3
33.3
8.3
8.3

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Participants ranged from 2146 years with an

average of 29.826.6 years. There were 12 (18%) volunteers with allergy history, 7 (58%) of whom were
hypersensitive to dust or pollen (Table 1). About
20% gloves were distributed without the evaluation
questionnaire being returned after the test wearing.
Most of the participants completed one to four
questionnaires, depending on the surgical schedule,
or failure to turn in or ll out the questionnaires, inability to nd the proper size, or unwillingness to
continue the trial. No dierential rates of unreturned questionnaires were observed among the four
groups. A total of 198 copies of questionnaire was
collected from the participants, 48 of which were for
brand A, 82 for B, 30 for C, and 38 for brand D.
The length of use was not signicantly dierent
among the 4 manufactures (Table 2). The frequency
of changing gloves during the surgical procedure,
excluding contamination, was 7 (3.5%), 4 of which
(1A, 2B and 1C) were due to glove perforations, 1
(D) was soaking wet from sweating and 2 (D)
caused uncomfortable reactions.
Of the 198 tested pairs of gloves, none of them
were found with defects prior to the operation.
Seven gloves, 2 right-hand and 5 left-hand, were
observed with holes or tears after the surgical procedure. The defect rate post operation in doctors,
3.7% (4/109), was about the same as that in other
surgical personnel, 3.4% (3/89), p=0.9. Gloves
worn longer than 2 hours had a slightly higher perforation rate (11.5%, 3/26) than those worn 2 hours
or less (2.1%, 3/142), p=0.048. None of the other
variables were associated with the wearing-time. A
total of 15 hypersensitivity events was reported by 7
(10.6%) participants in this trial, seven of which
occurred when brand A was worn. The event rates
were signicantly dierent among the four groups
( p < 0.05). However, no signicant dierence of
allergic reaction was found between gloves worn by
those with and without previous allergy history,
7.7% (3/39) vs. 7.5% (12/159), respectively, or
between surgeons (8.3%, 9/109) and the other surgical sta (6.7%, 6/89), p=0.7. Most common
observed reactions were itching and skin rash, with

277

278

K.-L. Hwang et al.

Table 2. Mean length of use (min) by brands

Brands
A
B
C
D
Overall

No.

Mean2S.D.

Median

Range

40
74
23
31

64.1238.1
95.8287.0
87.8256.4
83.4256.7

60
60
90
60

3150
10600
10240
0180

168

84.9269.3

60

0600

Table 3. Glove-wearing time-adjusted odds ratio of quality measures from generalized estimation equations (GEE)
method
Brand

Events

Odds Ratio
(95% C.I.)

Odds Ratio
(95% C.I.)

Odds Ratio
(95% C.I.)

0.39
(0.044.22)
7.30*
(1.536.2)
1.58
(0.55.0)
6.12**
(1.524.8)
5.85*
(1.130.5)
14.9**
(4.055.5)
43.5**
(4.7402.9)
20.4**
(4.493.6)
7.02**
(2.420.3)

1.53
(0.268.9)
2.92
(0.7611.2)
2.40
(0.668.7)
5.60
(0.9134.4)
6.17
(0.7650.3)
4.80
(0.9524.3)
11.6*
(1.1118.5)
6.0*
(1.0135.7)
2.13
(0.4310.6)

2.21
(0.578.5)
5.11
(0.4953.4)
1.96
(0.685.6)
10.9**
(2.448.9)
19.4**
(3.1122.5)
24.23**
(7.282.0)
26.1**
(3.5191.6)
10.5**
(2.151.3)
7.86*
(2.524.8)

Changing gloves during operation

Allergy
Not proper size or poor t
Poor ventilation
Poor elasticity
Too thick or too thin
Too much or too little powder
Unsatisfactory
Do not suggest to purchase
* : p<0.05.
** : p<0.01.

surgical procedures, 858% (Albin et al., 1992;

Chapman and Du, 1993; Avery et al., 1998;
Newsom et al., 1998). During the surgeries with the
electrocautery procedure, none of the participants
experienced electric punctures which usually

occurred when unnoticed pinholes existed. That procedures longer than 2 hours posed a higher risk of
perforations was also consistent with studies by
Miller and Apt (1993) and Hansen et al. (1992).
However, we did not nd surgeons with a greater

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Fig. 1. Results of glove-quality evaluation. *: p<0.05; **: p<0.01 by w2 test or Fisher's exact test when appropriate.

Evaluation of the quality of surgical gloves among four dierent manufacturers

cause hypersensitive reactions''; a similar action was

taken by US FDA seven years ago. However, it is
more essential to identify patients who are at high
risk of hypersensitivity to rubber products, and
latex-free gloves should be used for the procedure
on these patients to avoid severe reactions, i.e., anaphylactic shock or death. To further investigate the
prevalence of latex allergy in Taiwanese, the skin
prick test or other serology studies need to be performed on the people who routinely wear rubber
gloves or are constantly exposed to latex antigens.
Other features of the surgical gloves have yet been
discussed in literature, such as ventilation, tness,
thickness, amount of the corn starch powder and
elasticity. We think that they are also important for
the quality of the patient care, although not in direct
ways. For example, surgical personnel may suer
from sweating in gloves with poor ventilation;
poorly tting glove sizes and thickness, inappropriate amount of the corn starch powder and poor
elasticity may make wearers uncomfortable or less
sensitive, and, in consequence, aect the performance of the procedure. According to our study, the
most common problem among 4 brands was the t.
From 20% (brand B) to 76% (brand D) of the participants found the gloves either too big/loose or too
small/tight, though most of them had already picked
up the most suitable glove sizes. Since most of the
gloves were imported directly from western
countries or made by models designed for
Caucasians, the length of ngers was therefore too
long for Orientals even though the wrist and palm
parts tted properly. Less than 8% of the participants scored brand B unfavourably for ventilation,
elasticity, thickness, amount of powder and satisfaction, while the others had more than 15% unfavourable scores for these features. Poor thickness and
inappropriate amount of powder were recorded by
more users of brands A and D, 4284%, than those
of brands B (56%) and C (23%), p<0.01. Brands
A and C were 56 times more likely to have poor
ventilation and elasticity than brand B, while brand
D had even higher odds ratios of these two
measures, 11 and 19, respectively. However, the
odds ratios of these two measures for brand C did
not reach the signicant level due to a relatively
small sample size. The results of satisfaction and
suggestion to purchase for each specic manufacture
were consistent with the overall pictures of these
measurements, i.e., B was the most favoured brand,
A and D were the least satisfactory ones, and C was
in between. Our newly adopted surgical glove,
brand B, has achieved ISO-9001 and ISO-9002 standards, and also meets the FDA requirement. With
the comments and suggestions proposed by our trial
participants, mostly about the nger length, the
manufacture is now working on the improvement of
their product to provide a better quality for their
customers. This is also a positive interaction

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chance to have post-procedure glove perforations

compared to the rest of the surgical group. To conclude that the gloves provide sucient protection
for both surgical workers and patients will need
more comprehensive investigation.
Allergy to latex is the major concern for most of
the surgical gloves users, especially persons with
atopy. Although we did not perform the skin test
for the latex allergy, we considered that the symptomatic reactions would aect the performance of the
surgical procedure in a more direct way. In this
study, the hypersensitive reaction rate of individuals
with the history of allergy did not appear to be
higher than those without the history. The rates of
symptomatic allergy among our participants, 6.7%
among non-surgeons and 8.3% among doctors,
were a little bit lower than those from other studies,
1241% (Lagier et al., 1992; Amin et al., 1996; Liss
et al., 1997). Dierent populations may have dierent serological response rates to dierent antigenic
components of rubber tree sap (Kurup et al., 1993).
Although most of our reported adverse reactions
were cutaneous symptoms, the entire study population, with a median age of 29 years, was apparently younger than that of other studies, for
examples, the mean age of Lagier's study subjects
was 35.426 years (Lagier et al., 1992), and 80% of
Liss's participants were older than 30 years of age
(Liss et al., 1997). Slater (1994) indicated that
health-care professionals appeared to have a progression of occupational symptoms, from cutaneous
reactions to rhinoconjunctivitis to bronchospasm
and anaphylaxis. With a great portion of young
nurses who had exposed to surgical gloves for only
one to three years, we may expect a growing trend
in both percentage and severity of the hypersensitivity to latex gloves among our operating room personnel in the future. It was also stated that
powdered latex gloves were more dangerous because
of the aerosolization of antigen (Tarlo et al., 1994;
Sussman and Beezhold, 1995; Woods et al., 1997).
Although more and more surgical workers are
aware of the adverse reactions to latex gloves, little
attention has been paid to the potential risk of
severe outcomes for high risk patients. Without the
knowledge of whether or not the patient is hypersensitive to the surgical gloves, choosing a manufactured product that causes fewer allergic reactions
will be highly recommended. Latex avoidance practices are proposed at various degrees from centre to
centre in the United States. Some centres have latexfree area in surgical rooms and dental clinics, and
others reserve the rst morning time slot for procedures on patients with latex allergy (Korniewicz
and Kelly, 1995; Woods et al., 1997). Recently, the
department of health (DOH) in Taiwan requested
that all the glove manufactures put a warning message on the top of the gloves boxes which states that
``the gloves are made in natural latex and might

279

280

K.-L. Hwang et al.

between the medical service providers and medical

instruments providers.
This trial focused on the individuals' responses
from our operating room health workers in terms of
a general evaluation of four dierent brands of surgical gloves adopted by other medical centres and
hospitals. To our surprise, the quality of the products varies widely from manufacture to manufacture. Although a large lot to lot variance may exist
within an individual manufacture, the inferior evaluation results of tested glove samples provided by
specic companies, e.g., A and D, may also reect a
poor quality control. For the recommended brand,
B, we are still following up the complaints and satisfaction from the surgical workers. Latex-free gloves
have been applied to individuals with a history of

allergy to rubber gloves, and length of nger parts

are modied by the company. To date no notable
comments and events have been led for the past six
months.
In addition to the budget consideration, a good
and comfortable barrier protection to both microorganism infection and body uid contamination is
important. The quality of latex gloves calls for a
standard requirement regulated by the government
to provide a safe and comfortable environment for
the health-care workers.
AcknowledgementsThe authors thank Lie-Ling Wu, MS,
and Dr. John Bruce, for their assistance in editing this
manuscript. Gratitude is expressed to CCH surgical sta
who participated in this trial.

Employee No.: __
Surgical Room No.: __
Date: __ / __ / __
Name/Purpose of the pro______
Length of use: __ hr __ min
cedure:
1.0. Was one pair of gloves worn throughout the procedure? __ 1. No __ 2. Yes (Skip to 2.0)
1.1. Number of pairs used during the same procedure
__ Pairs
1.2. Length of use for the 1st pair (Brand code __)
__ hr __ min
Length of use for the 2nd pair (Brand code __)
__ hr __ min
1.3. Reasons for changing
__ 1. Defect prior to use
gloves?
__ 2. Allergic reaction
__ 3. Perforation or electrical puncture
__ 4. Sweating wet
__ 5. Too big/small (Circle one)
__ 6. Others ______
2.0. Please answer the following questions for one specic pair of gloves. If more than one pair was
used, please use separate questionnaires for dierent pair.
Brand code: A B C D (Circle one)
1.
2.
3.
4.

Defect prior to use

Perforation post use
Electric puncture
Reasons for perforation

5. Size and tness

6. Allergic reaction
7. Symptoms of allergy
8.
9.
10.
11.
12.
13.

Ventilation
Elasticity
Thickness
Amount of powder
Overall satisfaction
Suggest to purchase

Left Hand
Right Hand
__ 1. No __ 2. Yes
__ 1. No __ 2. Yes
__ 1. No __ 2. Yes (__ holes)
__ 1. No __ 2. Yes (__ holes)
__ 1. No __ 2. Yes (__ times)
__ 1. No __ 2. Yes (__ times)
__ 1. Being cut
__ 1. Being cut
__ 2. Being punctured
__ 2. Being punctured
__ 3. Torn
__ 3. Torn
__ 4. Defect prior to use
__ 4. Defect prior to use
__ 5. Unknown reason
__ 5. Unknown reason
__ 6. Others ______
__ 6. Others ______
__ 1. Just right
__ 2. Too big/loose
__ 3. Too small/tight
__ 1. No (Skip to 8) __ 2. Yes
__ 1. Rash
__ 2. Eyes symptoms
__ 3. Respiratory symptoms
__ 4. Itching
__ 5. Others
______
__ 1. Good
__ 2. Fair
__ 3. Poor
__ 1. Good
__ 2. Fair
__ 3. Poor
__ 1. Too thick
__ 2. Adequate
__ 3. Too thin
__ 1. Too little
__ 2. Adequate
__ 3. Too much
__ 1. Good
__ 2. Fair
__ 3. Poor
__ 1. No
__ 2. Yes
__ 3. No opinion

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Appendix: Sample of the Evaluation Questionnaire

Evaluation of the quality of surgical gloves among four dierent manufacturers

281

14. Other comments:

Denitions:
1. Defects refers to holes, tears and other defects recognized by visual inspection.
2. Perforation refers to visible pinholes which were not noticed by prior inspection before use.
8. Poor ventilation indicates that the gloves cause sweating easily.
10. Poor elasticity indicates that the gloves cannot attach to the skin properly.

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