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PFR95 Particulate Filter Respirator and Surgical Mask Regular Size, PFR95 Particulate Filter Respirator and Surgical

by Tecnol Medical Products, Inc.

510(k) K974068

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK974068 Date22 Dec 1997ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2626-2023 FDA Class II initiated 9 Aug 2023

    One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

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