A: Medical gloves are intended to provide broad barrier protection. Please see current recommendations from Center for Disease Control and Prevention (CDC) for patients with suspected or confirmed COVID-19. At this time, FDA has not cleared, approved, or authorized any medical gloves for specific protection against the virus that causes COVID-19 or prevention of COVID-19 infection.

A: The FDA issued a guidance document entitled Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency to provide a policy to help expand the availability of these items for health care professionals. This document includes the FDA’s policies regarding surgeon’s and patient examination gloves during the COVID-19 pandemic.

A: The FDA’s policy applies to these types of gloves:

The FDA’s policy does not apply to powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove. See this Final Rule on Banned Devices for details. These products are banned devices and are not eligible to be distributed in the United States.

A: To identify FDA-cleared medical gloves, search the 510(k) Premarket Notification database using the product codes for medical gloves listed in the previous Q&A.

A: If you are a part of a group purchasing organization (GPO), you may want to contact the GPO staff to determine what communication they receive from their suppliers; otherwise, you can contact manufacturers directly.

A: Medical gloves were designed to serve as protective barriers and may still offer some protection even when they are used beyond the manufacturer’s designated shelf life or expiration date. The user should inspect all gloves prior to use and if there are concerns such as discoloration, visible holes or tears, the product should be discarded. As a conventional capacity strategy, it is preferred that expired gloves are used where barrier protection is not needed.

A: The manufacturer-designated shelf life or expiration date may be found in the product labeling or packaging, or you can contact the manufacturer directly.

A: The FDA generally does not recommend reuse of gloves. The FDA recognizes that there may be availability concerns with gloves during the COVID-19 public health emergency, but there are strategies to conserve gloves.

A: The FDA issued a Letter to Health Care Providers on Medical Glove Conservation Strategies that describes these recommended strategies:

• Conventional capacity strategies
• Contingency capacity strategies
• Crisis or alternate strategies if medical gloves are running low or not available

A: During the COVID-19 public health emergency, the FDA does not expect manufacturers to submit notification to FDA before they begin marketing their product or to comply with certain regulatory requirements where the medical gloves do not create an undue risk in light of the pandemic as outlined in the FDA’s policy for gloves that is in effect during the COVID-19 public health emergency.

Under the policy, the FDA believes patient examination gloves do not create such an undue risk where:

• The gloves include labeling that:
  • Accurately describes the product as an “unpowdered glove” (as opposed to a “surgeon’s glove”);
  • Accurately describes of the product’s sterility status (i.e., non-sterile);
  • Does not claim that the product is latex-free or otherwise free of a specific material;
  • Includes a list of the body contacting materials; and
  • Includes recommendations and general statements that would reduce the risk of use. For example:
    • A statement that the gloves have not been cleared by FDA.
    • A recommendation against using when FDA-cleared gloves are available.
    • A recommendation against using in surgical settings.
• The product is not intended for any use that would create an undue risk. For example, the labeling does not include uses with chemotherapy drugs, fentanyl, and other opioids, for allergy or dermatitis prevention, for antimicrobial or antiviral protection, or for infection prevention or reduction.

Under the policy, the FDA believes that surgeon’s gloves do not create such an undue risk where:

• The gloves meet the standard described in ASTM D3577 and have been manufactured in compliance with good manufacturing practices.
• The gloves include labeling that:
  • Accurately describes product as being unpowdered;
  • Accurately describes the product’s sterility status (i.e., sterile) and the sterilization method used;
  • Does not claim that the product is latex-free or otherwise free of a specific material;
  • Includes a list of the body contacting materials; and
  • Includes recommendations and general statements that would reduce the risk of use. For example:
    • A statement that the gloves have not been cleared by FDA.
    • A recommendation against use when FDA-cleared surgeon’s gloves are available.
• The product is not intended for any use that would create an undue risk. For example, the labeling does not include uses with chemotherapy drugs, fentanyl, and other opioids, for allergy or dermatitis prevention, for antimicrobial or antiviral protection, or for infection prevention or reduction.

A. The FDA does not have a list of materials used to make gloves. However, in our experience, gloves are most often made of different materials, including nitrile, polyvinyl chloride (PVC), polyurethane, and neoprene.

Please be aware that powdered gloves are banned pursuant to the Final Rule on Banned Devices for powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove.

A: The American Society of Testing and Materials provides information regarding standards for various personal protection equipment. The FDA had also previously issued the Medical Glove Guidance Manual.

A: The FDA does not have patterns or templates for medical gloves to share with the public or recommendations regarding materials beyond those listed in the standards referred to in the previous answer.

A: If you have read the Enforcement Policy guidance document as well as the information on this page and you have questions, send an email to CDRH-COVID19-PPE@fda.hhs.gov.

A: In order to avoid delays of legitimate shipments, review the Importing COVID-19 Supplies and FDA’s instructions to importers for important information surrounding importing products, including gloves, to ensure that the proper documentation is submitted at the time of entry. The FDA has been ready and available to engage with importers to minimize disruptions during the importing process. If you have any specific import questions, you may email COVID19FDAIMPORTINQUIRIES@fda.hhs.gov.

A: No, you do not need to apply to FDA for issuance of an Emergency Use Authorization (EUA) to import medical gloves.

A: The FDA does not maintain a list of glove suppliers. If you are a health care facility, check with your supplier, distributor, or your local health department.  You may also want to check with the Association for Health Care Resource & Materials Management (AHRMM) of the American Hospital Association, which maintains the AHRMM Novel Coronavirus (COVID-19) Update on health care supply chain issues.

A:  The FDA does not issue any kind of certification to demonstrate that a manufacturer is in compliance with the FDA’s requirements. The FDA recommends that manufacturers follow recognized standards for testing of gloves. You may consider asking for that information when purchasing gloves.

A: The FDA does not have an exhaustive list of all counterfeit or fraudulent products. To report fraudulent COVID-19 products to the FDA, email FDA-COVID-19-Fraudulent-Products@fda.hhs.gov.

A: The FDA does not purchase or distribute gloves. If you are interested in donating gloves, see COVID-19 Offer of Medical Supplies or Equipment.

A: The FDA encourages users and facilities who are concerned about distribution of a medical product, or anticipate a potential or actual shortage, to notify the FDA. For potential or actual supply issues, email information to the FDA at deviceshortages@fda.hhs.gov.

Device manufacturers that are required pursuant to section 506J to notify FDA of an interruption or permanent discontinuance in manufacturing should submit their notifications via email to CDRHManufacturerShortage@fda.hhs.gov during the COVID-19 public health emergency.  Please begin the email subject line with the word "Notification."  The FDA released an immediate in effect guidance to assist manufacturers in providing the FDA with timely and informative notifications about changes in the production of certain medical device products that will help FDA prevent or mitigate shortages of such devices during the COVID-19 public health emergency. The FDA revised this guidance to include a list of device types and corresponding product codes that FDA recommends manufacturers consider in determining whether they are required to notify FDA pursuant to Section 506J during the COVID-19 pandemic. This list represents FDA’s current understanding of the circumstances described above. This list is not exhaustive, and FDA intends to update this list as the COVID-19 pandemic evolves. The FDA will publicly announce any changes to this list.

A: The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with medical gloves.

• Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
• Device manufacturers and user organizations must comply with the applicable Medical Device Reporting (MDR) regulations.
• Health care personnel employed by organizations that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their organizations.