1. Does the FDA or USDA officially certify gloves?

  2. What are the storage guidelines for gloves?

  3. What is the difference between latex and vinyl gloves?
    1. What is natural rubber latex?
    2. What is a latex allergy?
    3. How do I know if I have a latex allergy?
    4. What should I do if I have a latex allergy?
    5. Why don't they just use non-latex products on everyone?
    6. How can we prevent latex allergy?

  4. Why choose powder-free gloves?

  5. 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.


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).


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.


    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.).


    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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