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Conphar Face Mask-Sterile

by Conphar, Inc. 510(k)

Active United States

510(k) K792110

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK792110 Date5 Nov 1979ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A sterile surgical face mask designed to protect the patient’s operative field from contamination during surgical procedures. Classified under product code FXX, this device is intended for single-use in general and plastic surgery settings to maintain aseptic conditions.

Supplied sterile and intended for one-time use, the mask is regulated under FDA 510(k) clearance (K792110) with a traditional review pathway. Manufactured by Conphar, Inc. in Mchenry, Illinois, it adheres to standards for surgical draping and barrier protection, ensuring compliance with procedural sterility requirements.

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