Personal protective equipment (PPE) refers to protective clothing, helmets, gloves, face shields, goggles, facemasks and or respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness.
PPE is commonly used in health care settings such as hospitals, doctor’s offices and clinical labs.
When used properly, PPE acts as a barrier between infectious materials such as viral and bacterial contaminants and your skin, mouth, nose, or eyes (mucous membranes). The barrier has the potential to block transmission of contaminants from blood, body fluids, or respiratory secretions.
PPE may also protect patients who are at high risk for contracting infections through a surgical procedure or who have a medical condition, such as, an immunodeficiency, from being exposed to substances or potentially infectious material brought in by visitors and healthcare workers.
Under the Emergency Use Authorization (EUA), the FDA accepts marketing authorization from Australia, Brazil, Europe, Japan, Korea, and Mexico who have similar standards to NIOSH (National Institute for Occupational Safety and Health).
When evaluating whether these products are intended for a medical purpose, among other considerations, FDA will consider whether:
● they are labeled or otherwise intended for use by a HCP (Health Care Professional)
● they are labeled or otherwise for use in a health care facility or environment
● they include any drugs, biologics, or anti-microbial/anti-viral agents.
Face masks, face shields, and N95 respirators are medical devices, when they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease.
FDA revoked Emergency Use Authorizations for Non-NIOSH-Approved Disposable Respirators and Decontamination Systems, as access to FDA-authorized and NIOSH-approved N95s increases nationwide.
On June 30, 2021, the FDA announced the revocation of the following EUAs:
- Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (effective July 6, 2021)
- Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (effective July 6, 2021)
- Decontamination and Bioburden Reduction System EUAs for Personal Protective Equipment (effective June 30, 2021)
As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings.
Before you send your purchase order:
● Determine whether the manufacturer is registered with the FDA, and has a DUNS Number.
● Ask the manufacturer to provide Owner / Operator Number.
● Request the Listing Number for each product.
● Make sure you have your company’s Employer Identification Number (EIN) and DUNS Number.
Then, contact ITB HOLDINGS LLC to register your company as Medical Device Establishment.
Companies (establishments) that are involved in the production and distribution of medical devices intended for use in the United States, are required to register and list their products with the U.S. Food and Drug Administration, then renew their registration between October 1 and December 31, each year.
A foreign company or registrant must provide the name, address, and phone number of the foreign registrant’s U.S. Agent, such as ITB HOLDINGS LLC.
The U.S. Food and Drug Administration will not confirm a registration, provide an FDA Establishment Identification (FEI) number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.
The FDA recognizes the DUNS Number as an acceptable Unique Facility Identifier (UFI) for the purpose of registrations. The DUNS number is assigned and managed by Dun & Bradstreet (D&B) Inc. DUNS numbers can be obtained or confirmed by visiting D&B’s website.
If you are a part of a group purchasing organization (GPO), or a manufacturer in China, India, Mexico, Europe, you may want to contact ITB HOLDINGS LLC.
