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- Does the FDA or USDA officially certify gloves?
- What are the storage guidelines for gloves?
- What is the difference between latex and vinyl gloves?
- What is natural rubber latex?
- What is a latex allergy?
- How do I know if I have a latex allergy?
- What should I do if I have a latex allergy?
- Why don't they just use non-latex products on everyone?
- How can we prevent latex allergy?
- Why choose powder-free gloves?
- What is the difference between exam grade and disposable grade gloves (also known as general purpose)?
1. Does the FDA or USDA officially certify gloves?
No. Neither the FDA nor the USDA officially "certifies" gloves for
entry into the United States. What the FDA does require, however, is
for manufacturers of all examination (medical grade) gloves to have
510(k) device listings on file with the agency. This means that the
manufacturer has been tested and approved to manufacture gloves for
medical use (typically involves ISO certification, as well). This does
not mean that the gloves themselves have been officially approved or
certified for medical use. The FDA conducts random testing on
containers of examination gloves as they enter the U.S.
Similarly, the USDA does not "officially certify" any
disposable gloves as they enter U.S. ports. The USDA provides strict
guidelines for the manufacture, storage and transport of gloves, and
makes it incumbent upon the manufacturers and distributors to maintain
the integrity of the goods. The USDA allows manufacturers and importers
to list their goods as "accepted" (but not "approved") for food service
use as long as the goods comply with their guidelines.
While no manufacturer can market exam or industrial gloves as
FDA or USDA "approved" or "certified", DirectGlove disposable gloves do
meet or exceed all USDA and ASTM standards. Our factories, moreover,
are all ISO and CE certified to comply with international standards of
quality and excellence.
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2. What are the storage guidelines for gloves?
Always
store gloves in the original packaging in a cool, dry and well
ventilated area. Stay away from dust, sunlight, moisture, X-ray, and
excessive heat above 100 F (37 C). Top
3. What is the difference between latex and vinyl gloves?
Latex gloves are manufactured from natural rubber latex derived from the sap of the rubber tree, Hevea brasiliensis. Because of the inherent elasticity of latex, the fit is more conforming
and comfortable. However, natural rubber latex also contains proteins
to which some users may be sensitive. While most allergies or
sensitivities are generally slight, a very small percentage of users
may experience severe reactions.
Vinyl gloves are manufactured from polyvinyl chloride, a
petroleum-based compound. While not quite as form-fitting as latex
gloves, they contain no proteins to irritate the skin. They also
possess increased resistance to certain cleaning compounds and
chemicals. Vinyl gloves are the preferred choice for users sensitive to
latex.
While latex and vinyl both provide excellent barrier
protection, latex is recognized as having superior barrier qualities.
Some people still prefer the fit and form of latex, especially in
applications where comfort and tactile sensitivity are paramount.
3a. What is natural rubber latex?
Latex is a sap produced by rubber tree, and after it is processed
with heat and chemicals, it is known as natural rubber. This rubber
is widely used in medical equipment and supplies, including surgical
gloves.
3b. What is a latex allergy?
A latex allergy, or hypersensitivity, occurs when a person's body's
immune system reacts to the latex proteins and/or the additives used
during the manufacturing process. The reactions range from mild:
skin rash, runny nose, itchy, watery eyes, to an extreme of: facial
or throat swelling, and difficulty breathing.
3c. How do I know if I have a latex allergy?
The only way to know for sure if you have a true latex allergy is to
have allergy testing done. Some examples of common reactions that
may be sign of latex allergy problem, may include:
Skin rashes or reactions on your hands from wearing rubber gloves.
Rashes on your face or skin from touching it if you did not wash your hands after wearing rubber gloves.
Tingling, swelling or rashes on your lips or face after blowing up a balloon, or having rubber products near your face.
Skin rashes, itching, or swelling from wearing clothes with elastics next to your skin, such as a bra or underwear.
3d. What should I do if I have a latex allergy?
Contact an allergist or health care professionals immediately to
determine the cause of the allergy. You should tell the health care
professionals before you receive care, so that products that don't
contain latex can be used for your care.
3e. Why don't they just use non-latex products on everyone?
This would be difficult because there is not always a latex free
substitution for a product. In some instances, it would also be very
expensive. Most people have no problems, and use latex products all
their life. However, for some people who have developed this
allergy, latex-free products are the only solution. There is also
the risk of not knowing if you have an allergy to latex...The only
way to truly prevent latex allergies from occurring is avoiding
products that contain latex.
3f. How can we prevent latex allergy?
Latex allergy can be prevented by protecting workers from latex exposure.
Employers should:
- provide workers with non-latex gloves (e.g.: synthetic, nitrile, vinyl gloves)
- ensure that workers use good housekeeping practices to remove latex-containing dust from the workplace
- provide workers with education programs about latex allergy
"Hypoallergenic"
gloves are usually made from latex so latex-sensitive workers should
check to see if they are made from latex or some other material.
People allergic to latex rubber products should consult an allergist to
find out if they are actually allergic to latex (natural) rubber or
to chemicals that are in synthetic rubbers. They should also advise
their physicians and dentists so that they can decide if alternate
products should be used in any treatment that normally requires the
use of rubber products.
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4. Why choose powder-free gloves?
Powdered
gloves are used by the majority of users, accounting for nearly 70% of
total glove usage. The corn starch powder makes the gloves easier to
wear, and they are generally less expensive than powder-free gloves.
However, the popularity of powder-free gloves has grown every year due
to the increased awareness of latex allergies and the preference for a
latex glove with a low-protein count. DirectGlove gloves are washed in
a chlorine solution, which lowers their latex protein levels and
reduces the likelihood of latex sensitivity. Powder-free gloves,
whether they are latex or vinyl, are also preferred for use in specific
environments that cannot be contaminated with powder (e.g., electronic
assembly plants, laboratories, crime labs, etc.).
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5. What is the difference between exam grade and disposable grade gloves (also known as general purpose)?
As
mentioned, exam or medical-grade gloves must meet a series of FDA
regulations in order to be marketed as exam grade. Disposable or
General Purpose gloves are, in fact, exam grade gloves that did not
quite pass the FDA mandated quality control tests. While no one
intentionally manufactures a Disposable / General Purpose glove,
DirectGlove gloves are manufactured as medical grade gloves, yet do
undergo the final steps of the FDA testing process. This gives
DirectGlove Disposable grade gloves a near-exam level of quality.
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For some glove education, click here!
Still have questions? Please submit your questions to:
info@directglove.com
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