U.S. Department of Labor

Occupational Safety and Health Administration

Directorate of Science, Technology and Medicine

Office of Occupational Medicine

This Safety and Health Information Bulletin is not a

standard or regulation, and it creates no new legal obligations. The Bulletin is advisory in nature, informational in content, and is intended to assist employers

in providing a safe and healthful workplace. The Occupational Safety and Health Act requires employers

to comply with safety and health standards as issued

by either the Federal Occupational and Health Administration (OSHA) or an OSHA approved state

plan. In addition, pursuant to Section 5(a)(1), the

General Duty Clause of the Act, employers must provide their employees with a workplace free from recognized hazards likely to cause death or serious physical harm. Employers can be cited for violating the

General Duty Clause if there is a recognized hazard

and they do not take reasonable steps to prevent or

abate the hazard. However, failure to implement any

specific recommendations in this safety and health information bulletin is not, in itself, a violation of the

General Duty Clause. Citations can only be based on

standards, regulations, and the General Duty Clause.

SHIB 01-28-2008

Safety and Health Information Bulletin

Potential for Sensitization and Possible Allergic Reaction To Natural

Rubber Latex Gloves and other Natural Rubber Products

Purpose

This safety and health information bulletin updates

TIB 99-04-12 and informs field personnel,

employees and employers about issues regarding

sensitization and allergic reactions that have

occurred in some individuals using natural rubber

latex (NRL) products, particularly gloves, in the

workplace setting. This bulletin can also provide

information to personnel, especially health care staff,

who use gloves as personal protective equipment or

use other NRL products in their workplace.

Background

Natural rubber is utilized in a variety of products,

including gloves, airways (e.g., for intubation),

airway masks, medication vial tops, anesthesia bags,

various catheters, supplies for intravenous use,

dental dams, balloons, and other items.1,2,3 NRL

glove use in the health care setting has risen

dramatically since about 1987 due to increased

awareness about the risk of contracting HIV,

hepatitis B and C, and other infectious agents in the

course of delivering health care to patients.1,4 Thus,

the frequency of exposure to NRL among health

care and other employees has increased.

NRL products are also used to provide barrier

protection from disinfectants and other chemicals

and agents in health care and other environments.

(NOTE: While NRL gloves provide an effective

barrier for certain purposes, they are not universally

suitable. The material properties and construction of

a glove suitable for barrier protection must be

determined in advance of use. Gloves appropriate

for protection from the particular chemical or agent

must be used). In some workplaces (e.g.,

electronics, drug manufacturing, and food

preparation), gloves are used to prevent

contamination of products. NRL gloves have also

appeared in some workplaces where there is a

perceived need to protect employees from an

exposure such as toll booths, post offices, and day

care settings. Natural rubber-containing articles are

manufactured in a variety of workplaces (e.g.,

manufacturers of medical gloves, industrial gloves,

balloons, rubber bands, boots and shoes, and many

other products).
2

Health Issues

With more widespread use of NRL gloves after

1987 there was an increase in reported NRL

sensitization and allergic reactions among patients

and among employees, notably health care

employees. In rare cases, these allergic reactions

can be fatal. In addition to reports from the

dermatology, allergy, and pulmonary literature of

severe skin and respiratory symptoms, life

threatening reactions associated with use of NRL

products have been noted in pediatric patients with

spina bifida who had repeated NRL exposure from

numerous surgical procedures.5,6,7 In addition, the

U.S. Food and Drug Administration (FDA) received

reports of numerous severe allergic reactions among

NRL-allergic patients, including some deaths,

associated with the use of NRL enema cuffs and

gloves.8

NRL is found in a variety of plants but is mainly

harvested from the rubber tree, Hevea brasiliensis.

The tree’s milky fluid (latex) contains variable

amounts of proteins. These proteins, when present

on a glove or adsorbed to glove powder, may be

absorbed through the skin or inhaled. Many of

these proteins have been characterized, with a

number of them designated as allergens by the

International Allergen Nomenclature Committee.9

Studies regarding these allergens are ongoing; some

researchers have noted that up to 60 protein

variations in NRL may be allergenic, or capable of

causing sensitization in some individuals.10,11,12

Some of these proteins, including some that are

allergenic for some individuals, can be eliminated

through the use of various processing techniques. A

number of studies indicate that corn starch powder,

often added to gloves to facilitate donning and

removal, serves as a carrier for the allergenic

proteins from the NRL. 2,3,13,14

In this document, “sensitization” or “sensitized”

refers to the presence of an immunoglobulin (IgE)

response to allergenic protein exposure. An

individual may or may not show any symptoms of

allergy, even though they are sensitized. “Allergic

response” refers to a skin reaction in response to a

skin prick test. “Allergic reaction” refers to (1) local

reactions such as a skin reaction in the area of

exposure in response to wearing gloves or a glove

challenge test, and (2) systemic reactions, which

occur beyond the body areas of exposure and lead

to various symptoms. This document refers to local

or systemic allergic reactions that cause symptoms

as “symptomatic.”

In addition to the above concerns, gloves, including

those made from NRL as well as some other

materials, may contain chemical accelerators such as

thiurams, carbamates, and benzothiazoles to which

an employee may develop an allergic contact

dermatitis. Antioxidants, biocides, soaps, and other

chemicals used in the processing of NRL products

may also contribute to this type of reaction.

Occupational Exposure Routes

The two major routes of occupational exposure are

dermal contact and inhalation. Inhalational exposure

can occur particularly when glove powder acts as a

carrier for NRL protein, which becomes airborne

when the gloves are donned, or removed.2,3,13

Allergenic proteins appear to be only a portion of

the total protein content of NRL gloves. It has been

noted that gloves with lower protein concentration

caused fewer positive responses to skin prick tests

than gloves with higher protein concentration;15 also,

higher total protein levels found on a glove generally

have included high levels of NRL allergenic

proteins.16 However, several investigators have

reported that glove NRL total protein content may

not necessarily correlate with allergenic protein

content, especially at lower protein levels.16,17,18,19 A

number of workplace interventions have indicated

that powder-free gloves with either lower total

protein or lower allergenic protein content reduced

risk of sensitization to allergenic NRL proteins or

allergic reactions in persons already

sensitized.20,21,22,23,24 Importantly, most interventions

have included the provision, and most investigators

recommend, that only non-NRL gloves be used by

those employees who are sensitized to or have

exhibited allergic reactions to NRL proteins. 25, 26
3

The majority of health care employees are able to

use NRL products to care for most patients.

However, some employees may develop sensitivity

to NRL upon repeated exposure. Variations exist in

the reported prevalence of NRL allergy. This

variation is probably due to different levels of

exposure and methods of estimating NRL

sensitization or allergy, as well as different study

populations and sampling methods. The prevalence

statistics in the studies mentioned below are based

on seroprevalence, skin prick test positivity and/or

allergic manifestations, and do not refer to the more

serious anaphylactic response, which is rare but

potentially life threatening in some individuals. In

one example of an investigation of health care

employees, a survey of active duty dental officers in

the U.S. Army reported that the prevalence of

allergic symptoms correlated with NRL use was

13.7%.27 An investigation of dental employees using

NRL skin prick testing at two consecutive American

Dental Association meetings in 1994 and 1995

revealed allergic responses in 9.1-9.7% of dental

hygienists and assistants, although dentists showed a

lower rate of 5.1-6.7%.

28 A 2000 - 2002 study of

dental hygienists using NRL skin prick testing found

allergic response in 4.8% of those studied.29 A study

of 247 nurses recruited at a nurses’ association

meeting revealed that 6.9% responded to a natural

rubber latex extract skin prick test, although the rate

for positive skin prick test together with a history of

symptoms associated with latex was somewhat less

(5.7%).30 Another article concluded that 8.9% of

741 inpatient nurses were seropositive for anti-latex

antibodies, an indication of sensitization.31 A study

of 168 anesthesiologists and nurse anesthetists

determined that 12.5% were sensitized (anti-latex

IgE antibody positive), but only 2.4% had

experienced allergic symptoms.32

Several papers have also addressed sensitization or

allergic response prevalence rates in the general

population or in populations perceived to be

surrogates for the general population. Examples

include: (1) a study of volunteer blood donors which

determined that 6.4% were seropositive for antilatex IgE antibodies, indicating sensitization to

NRL;33 and (2) a report that 6.7% of 996

ambulatory surgery patients were sensitized to NRL

(IgE anti-latex antibodies).34 In a review of a large

number of prevalence studies in occupationally

exposed groups, as well as in general populations in

North America and Europe, 2.9% -12.1% of

occupationally exposed groups, and under 2% of

general population groups, reacted to skin prick

testing, indicating allergic response to NRL.35 A

later analysis of prevalence studies found 6.9% to

7.8% of health care employees and 2.1% to 2.7%

of the general population reactive to skin prick

testing.36

Health care employees particularly affected include

operating room personnel, dental patient care staff,

special-procedure and general-medical nurses,

laboratory technicians, and hospital housekeeping

personnel consistently exposed to NRL.1, 37 NRL

sensitization or allergic response or reaction has also

been reported in greenhouse employees,38

hairdressers,39 doll manufacturing employees,40 and

employees in a glove manufacturing plant.41

Types of Reactions

Use of natural rubber products may result in

reactions that fall into the following three categories

(See also Types of Reactions table):

 (1) irritant contact dermatitis;

 (2) type IV delayed hypersensitivity (also called

allergic contact dermatitis); and

 (3) type I immediate hypersensitivity (also called

IgE/histamine mediated allergy).

These categories include reactions that vary from

localized redness and rash; to nasal, sinus, and eye

symptoms; to asthmatic manifestations, including

cough, wheeze, shortness of breath, and chest

tightness; to in some cases, severe systemic

reactions with swelling of the face, lips, and airways

that may progress rapidly to shock and, potentially,

death.

When gloves are associated with skin lesions, the

most common reaction is irritant contact dermatitis.

Irritant contact dermatitis may be due to direct
4

irritation from gloves or glove powder or may be

due to other causes, such as irritation from soaps or

detergents, other chemicals, or incomplete hand

drying. Irritant contact dermatitis presents as dried,

cracked, split skin. Although irritant contact

dermatitis is not an allergic reaction, the breaking of

the intact skin barrier due to these lesions may afford

a pathway for NRL proteins to gain access, and thus

promote development of sensitization.42,43,44 In

addition, irritant contact dermatitis lesions disrupt the

barrier function that intact skin provides to inhibit

passage of various chemicals and pathogens.

The second type of reaction that may be associated

with glove use is allergic contact dermatitis (also

known as type IV delayed hypersensitivity or allergic

contact sensitivity). When glove use has been

associated with this reaction, the majority of cases

appear to be due to the chemicals used in processing

NRL or other glove materials; a small percentage of

these reactions have been reported to be due to

NRL.45, 46 The allergic contact dermatitis has an

appearance similar to the typical poison ivy reaction,

with blistering, itching, crusting, oozing lesions. Also,

like poison ivy, this dermatitis appears 24-72 hours

after the use of gloves or exposure to other sources

of chemical sensitizers.

The third and potentially most serious type of

reaction sometimes associated with glove use is a

true IgE/histamine-mediated allergy (also called

immediate or type I hypersensitivity) to allergenic

glove protein [in the case of NRL allergy, to

allergenic NRL protein(s)]. This type of reaction can

involve local or systemic symptoms. Localized

reactions occur at the site of exposure. For

example, contact urticaria (hives), appearing in the

area where contact occurred, is a localized reaction.

Allergic rhino conjunctivitis and asthma following

exposure to airborne allergen are localized reactions.

Generalized reactions are those occurring at sites in

the body distant from the site of exposure. For

example, rhinitis or asthma after a skin exposure (or

hives at a site other than where the exposure

occurred) is a generalized reaction. The presence of

allergic manifestations to allergenic NRL protein

indicates an increased risk for anaphylaxis, a rare but

severe reaction experienced by some individuals

who have developed an allergy to certain allergenic

proteins (e.g., those present in NRL, some foods).

A type I reaction can occur within seconds to

minutes of exposure to the allergen (in the case of

NRL, to allergenic natural rubber proteins), either

by touching a product with the allergen (e.g.,

gloves) or by inhaling the allergen (e.g., powder to

which natural rubber proteins from gloves have

adsorbed). When such a reaction begins in highly

sensitive individuals, it can progress rapidly from

swelling of the lips and airways to shortness of

breath, and may progress to shock and death,

sometimes within minutes.

Any of these allergic signs and symptoms may be

the first indication of development of sensitization.

Sensitized employees with exposure to allergenic

NRL proteins can develop allergic reactions such as

skin (contact urticaria) and/or respiratory

symptoms. A number of studies indicate that

individuals with NRL allergy are more likely than

NRL non-allergic persons to be atopic (individuals

with an increased susceptibility for IgE response to

common allergens, with symptoms such as asthma,

eczema, or allergic rhinitis),30,47,48 or that atopic

individuals have an increased risk for developing

sensitization to allergenic NRL proteins.48 Once

symptomatic NRL allergic responses occur, allergic

individuals have continued to experience symptoms

on exposure to allergenic NRL proteins. These

symptoms have included life-threatening reactions,

not only on exposure to allergenic NRL proteins in

the workplace, but also upon receiving or

accompanying a family member receiving health

care services at inpatient as well as office-based

settings. In addition, such reactions have occurred

on exposure to consumer goods such as balloons,

condoms, and other products. Symptoms have also

occurred in some persons from exposure to certain

plants or foods (e.g., bananas, kiwi, avocados, and

chestnuts) with proteins that are cross-reactive with

NRL allergenic proteins, and allergic symptoms

have been reported by NRL allergic persons from

eating foods handled by food service employees

wearing NRL gloves. Moreover, some affected

individuals continue to experience asthmatic
5

symptoms even without known contact with NRL;

long-term treatment with steroids or other

medications may be necessary for managing

symptoms in these cases. Therefore, development

of symptomatic allergic responses to allergenic NRL

proteins in an individual may have lifestyle

implications beyond the workplace.

Recommended Strategies - Risk Reduction

It is of primary importance that barrier protection be

used when hands would otherwise contact infectious

materials or hazardous chemicals. OSHA’s

Bloodborne Pathogens Standard (29 CFR

1910.1030) requires that gloves be worn when it is

reasonably anticipated that hand contact may occur

with blood, other potentially infectious materials,

Types of Reactions
6

* The American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and

Immunology (ACAAI) issued a joint statement on July 21, 1997, which advises that latex glove purchase and use should

consist of only low-allergen, powder-free latex gloves. The National Institute for Occupational Safety and Health

(NIOSH) also recommends that if latex gloves are chosen, provide and use reduced protein, powder-free gloves.37 A

1998 Guideline for infection control in health care personnel, consisting of consensus recommendations of the Hospital

Infection Control Practices Advisory Committee (HICPAC) to the CDC, included several recommendations regarding

latex hypersensitivity, but did not include advice about use of powder-free gloves throughout an institution and made

no recommendation for institution-wide substitution of non-latex products in health care facilities to prevent sensitization to latex (Am J Infection Control 1998;26:339).

mucous membranes, non-intact skin, or

contaminated items or surfaces, as well as when

performing vascular access procedures [except as

specified in paragraph (d)(3)(ix)(D)]. When gloves

are being worn to protect against bloodborne

pathogens, the standard requires that employers

provide readily accessible alternatives (e.g., glove

liners) for employees who are allergic to the gloves

normally provided. NRL is a glove material that

has been used in the health care environment for

barrier protection for a number of years. In

response to reported NRL allergy in some patients

and health care employees, measures have been

recommended to reduce the risk of reactions to

allergenic NRL proteins in employees.

Primary prevention involves reducing potential

development of allergy by reducing exposure to

NRL allergenic proteins for all employees. Food

service employees, for example, use gloves as a

barrier to infectious agents that may be present on

their hands, and alternative gloves are available for

food handler use. Alternative materials are

appropriate for employees engaged in tasks such as

gardening activities. Gloves made of NRL as well

as alternative materials have been cleared for

marketing as medical gloves by the FDA and can be

used effectively for barrier protection against

bloodborne pathogens.49, 50 General administrative

procedures* that a facility can follow to reduce

employee exposure to NRL proteins include:

(1) If selecting NRL gloves for employee use,

designating NRL as a choice only in those

situations requiring protection from infectious agents;

(2) If selecting NRL gloves, choosing those that

have lower allergenic protein content. Selecting

powder-free gloves affords the additional benefit of

reducing response to environmental exposure; and

(3) Providing alternative suitable non-NRL gloves as

choices for employee use (and as required by

OSHA’s bloodborne pathogens standard [29 CFR

1910.1030, paragraph (d)(3)(iii)] for employees

who are allergic to NRL gloves).

Use of powder-free gloves has been shown to

reduce the dissemination of NRL proteins into the

environment and decrease the likelihood of reactions

by both the inhalation and dermal routes.2,14,23,51

Appropriate work practices when wearing handprotective equipment, including NRL gloves, include

avoidance of contact with other body areas such as

the eyes or face. Handwashing after glove removal

is required by OSHA’s Bloodborne Pathogens

Standard [paragraph (d)(2)(v)] and helps to

minimize powder and/or NRL remaining in contact

with the skin. Thorough clean-up of any residual

powder in the workplace using HEPA vacuums for

porous surfaces and either HEPA vacuums or wet

methods for nonporous surfaces will decrease

employees’ exposure as well.

Since the reason for wearing gloves is to provide

barrier protection from hazardous substances,

substitute materials must maintain an adequate

barrier protection and be appropriate for the hazard.

At a minimum, gloves made from NRL or other

materials and used for a medical purpose should be

labeled as medical gloves. Such gloves must meet

the FDA criteria for marketing, manufacturing, and

testing of medical gloves.

One institution has reported that a coordinated effort

to identify NRL sensitized individuals and reduce the
7

use of “high allergenic” natural rubber latex gloves

substantially reduced aeroallergen levels and costs.4

Another study reported that some NRL allergic

employees have been able to work wearing nonlatex gloves when their coworkers wore powderfree latex gloves.52 Several publications have

reported on the benefits of a facility-wide use of

only lower protein, powder-free gloves (with

already sensitized employees using non-latex

gloves). These benefits include a decrease in cases

of occupational asthma53 and other clinical latex

allergy symptoms,54 and a decrease in latex allergic

response confirmed by skin-prick test. 22,55 The

Department of Veterans Affairs mandated a

restricted use of latex gloves by hospital employees

in July of 1998, and a prevalence study done during

1999-2001 found sensitization documented by IgE

response in only 36 of 1,959 hospital employees

(1.8%).56 A teaching hospital, which converted to

low-protein, powder-free gloves, reported that

costs related to missed workdays and workers

compensation claims were reduced. This reduction

suggested an overall financial benefit from this

approach.22 Another institution studied several

facilities, demonstrating that regardless of size,

reduced disability and costs could be obtained by

replacing NRL exam gloves with gloves of alternate

material.57

FDA requires labeling statements for medical

devices that contain natural rubber and prohibits the

use of the word “hypoallergenic” to describe such

products.8

 NRL gloves with a reduced level of

chemical accelerators were once called

“hypoallergenic”; however, they must now be

labeled to eliminate confusion associated with the

former “hypoallergenic” claim and to provide more

specific information to the user. Some NRL gloves

and other devices produced before the effective

date of the FDA regulation (September 30, 1998)

may not carry the NRL labeling or may be labeled

“hypoallergenic’’. If such products are found in a

facility, these items should not be presumed to be

NRL-free; these gloves may still contain the NRL

allergenic proteins to which NRL sensitized

employees can react. It is important to note that

these FDA regulations do not apply to non-medical

devices, including utility gloves or food handling

gloves.

Recommended Employee Evaluation and

Management

The procedures outlined above may not be sufficient

to protect all individuals who have already

developed allergic symptoms on exposure to NRL

allergenic proteins. Health care facilities should

develop policies and procedures for reducing the

risk of allergic reactions to NRL allergenic proteins

in the workplace. The American College of Allergy,

Asthma, and Immunology has suggested that “safe

zones” (areas in which non-NRL products are used

and NRL allergenic proteins have been removed

from the environment) may be needed to protect

those employees who are already sensitized to NRL

allergenic proteins.5

Prudent risk reduction strategy involves an initial

survey and assessment, with a coordinated effort to

identify and catalogue all NRL products used in the

workplace. An ongoing program, involving close

coordination with resource and materials

management staff, should be established to monitor

the NRL content of incoming products so that

management staff can be prepared to choose

appropriate products for offering non-NRL

alternatives/low allergen content products to control

NRL allergenic protein exposure, as well as for

creating NRL safe zones.2 The contribution of glove

powder to allergenic protein levels in the workplace

environment should also be considered and use of

non-powdered gloves addressed. Mechanisms

should be in place for reporting, evaluating, and

managing cases of employees who experience

allergic symptoms related to exposure to NRL

allergenic proteins.

It is not possible, at present, to determine which

employees will become sensitized or symptomatic

on exposure to NRL allergenic proteins. Moreover,

the extent of an individual employee’s reaction, or

the length of time required for such allergic reactions

to develop in a sensitized employee, cannot be

ascertained.3 Finally, it is not possible, at present, to
8

predict which individuals will progress from

sensitization or from local contact urticaria to more

dangerous allergic reactions, nor when this

progression may occur.2,3 Laboratory and clinical

evidence indicates that an association exists between

allergy to some natural rubber proteins and allergy

to some proteins in certain foods and plants (e.g.,

avocado, banana, kiwi, chestnut)58,59 and some

aeroallergens (e.g., pollens, grasses).60, 61A history

of multiple surgeries has also been reported to be a

risk factor for NRL allergy.2,5 In some institutions,

periodic screening questionnaires for NRL allergic

symptoms in employees with current or past history

of significant NRL exposure (e.g., surgical

personnel) have been useful for ascertaining reaction

rates and managing those individuals experiencing

reactions.3,5 Questionnaires and diagnostic testing

have been determined to provide useful information

as part of exposure control in a hospital

occupational health program.22 A medical evaluation

of hand dermatitis by a physician experienced in

dermatologic diagnoses is essential for taking

preventive steps and assuring effective therapeutic

measures. Evaluation of signs/symptoms consistent

with allergic responses to some NRL proteins

should be accomplished under the direction of a

physician with expertise in NRL allergy, with

additional medical testing and treatment made

available if indicated.

Provision of NRL-free procedure trays and crash

carts for treatment of natural rubber allergic

individuals has been recommended.62 Although the

fundamentals of emergency response (i.e., assuring

an open airway, breathing, and circulation) remain of

primary importance should an employee develop

symptoms (including those caused by allergy to

some NRL proteins) requiring resuscitation, the

emergency needs of NRL-allergic individuals should

be anticipated in the workplace, including provision

of immediate access to non-natural rubber latex

containing equipment needed for successful

treatment.

Information Availability

Investigation continues into various aspects of NRL

sensitization and allergic response; our understanding of these issues continues to evolve.

Meanwhile, employers and employees need to be

aware of the present state of knowledge regarding

sensitization and allergic reaction to some NRL

proteins and how to address these issues.

Employees should be advised of symptoms that are

consistent with allergic reactions as well as primary

and secondary preventive measures for decreasing

the risk of (1) development of sensitization to NRL

proteins and (2) symptomatic responses in

employees who are sensitized.

NIOSH published a 1997 Alert titled Preventing

Allergic Reactions to Natural Rubber Latex in

the Workplace (NIOSH publication number 97-

135). NIOSH can be reached by calling 1-800-

35-NIOSH (800-356-4674), or through the

Internet http://www.cdc.gov/niosh/homepage.html.

OSHA field staff and consultation personnel should

be aware of the potential for sensitization and

possible allergic reaction to some NRL proteins

among some individuals in workplaces where NRL

products such as gloves are used.

Edwin G. Foulke, Jr.

Assistant Secretary

Occupational Safety and Health Administration
9

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10

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