FDA, Medical Gloves Regulation

Medical gloves are used by health care personnel to prevent the spread of infection or illness. Medical gloves are disposable and include patient examination gloves and surgeon’s gloves.

The FDA continues to take a number of steps to find and stop those selling unsafe and unapproved products by investigating, examining, and reviewing medical products, both at ports of entry and within domestic commerce, to help ensure the safety of our national supply chain.

To help expand the availability of medical gloves during the COVID-19 public health emergency, the FDA is providing regulatory flexibility under certain circumstances intended to prevent the devices from presenting an undue risk, as described in the enforcement policy for gloves during the COVID-19 public health emergency. The FDA is also providing regular updates about medical gloves, including the answers to frequently asked questions on this page.

FDA’s policy on medical gloves during COVID-19

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.

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.

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.

Manufacturing Gloves During COVID-19

During the COVID-19 public health emergency, the FDA does not expect manufacturers of gloves 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 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.

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.

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

Does the FDA have recommendations on patterns or templates to manufacture gloves?

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.

FDA Investigating Certain Imported Medical Gloves

The FDA recommends that health care facilities and providers do not purchase, or use imported medical gloves from companies included on Import Alert 80-04 Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves.

Companies are listed on an import alert when the agency has enough evidence to allow for detention without physical examination (DWPE) of their products as they appear to be in violation of the FDA's laws and regulations and thus, create a potential risk to health care professionals, patients and users.

To identify FDA-cleared medical gloves, search the 510(k) Premarket Notification database using the product codes for medical gloves.

When you have trouble importing gloves into the United States

In order to avoid delays of legitimate shipments, review the Importing COVID-19 Supplies and FDA’s instructions to importersExternal Link Disclaimer 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.

* Note: You do not need to request that the FDA issue an Emergency Use Authorization (EUA) to import medical gloves.

Provision Consulting Group provides consulting service and solves customer problems accurately and quickly.

Our services allow manufacturers to spend more time developing their devices

rather than searching for distributors, negotiating contracts, and learning regulations.

If you have questions about FDA regulation of medical devices

or importing of medical devices to the United States,

please CONTACT US.

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SOURCE :

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-gloves-covid-19