← Back to catalogue

Asept Surgical Face Mask

FDA 510(k)

Class II (US FDA 510(k))

510(k) K201137

by Pfm Medical, Inc.

Identifiers

510(k) Number
K201137 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)

Asept Surgical Face Mask is a surgical mask intended to provide a protective nose and mouth covering. It is classified as a Class II medical device under regulation 878.4040 with product code FXX.

The device was cleared via the FDA 510(k) pathway under submission K201137, with a decision of substantially equivalent issued on August 19, 2020. It is manufactured by Pfm Medical, Inc. and intended for use in general and plastic surgery settings.

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: Asept Surgical Face Mask 510 (k) K201137 - FDA.report, PDF K201137 Asept Surgical Face Mask - 510kdatabase.net, PDF Jessica Jho Director of Regulatory Affairs Trade/Device Name: Asept ..., fda.innolitics.com

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
Pfm Medical, Inc.

Sources (1)

  • FDA 510(k) K201137 24 fields · synced Sep 27, 2026