← Back to catalogue

PMW01 Procedure Mask Level 1

FDA 510(k)

Class II (US FDA 510(k))

510(k) K211772

by Defender Safety, Inc.

Identifiers

510(k) Number
K211772 FDA 510(k)
FDA Product Code
FXX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4040 FDA 510(k)
Regulation Number
878.4040 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The PMW01 Procedure Mask Level 1 is a surgical mask designed to protect both patients and healthcare personnel from the transfer of microorganisms, body fluids, and particulate matter during medical procedures. It adheres to ASTM Level 1 standards for fluid resistance and filtration efficiency, ensuring basic barrier protection in clinical settings.

This mask is supplied as a single-use, non-latex disposable device with an ear-loop configuration and an adjustable nose bridge. It is classified under FDA product code FXX and is intended for use in general and plastic surgery procedures. Sterility is not specified, and MRI safety is not applicable; storage should follow manufacturer guidelines to maintain integrity until use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K211772 - PMW01 Procedure Mask Level 1 - General Hospital, ASTM Level 1 Mask - Procedure Face Mask, FDA 510 (k ... - Defender Safety, PMW01 Procedure Mask Level 1 510 (k) K211772 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Defender Safety, Inc.

Sources (1)

  • FDA 510(k) K211772 24 fields · synced Oct 6, 2026