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O.R./Surgeons Gown, Item No. 4942

by The Sewing Source, Inc.

510(k) K921157

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK921157 Date9 Jul 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
FYA
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

The O.R./Surgeons Gown, Item No. 4942 is a surgical gown intended for use by operating‑room personnel and surgeons. It provides a barrier to protect both the wearer and the patient from the transfer of microorganisms and bodily fluids during procedures.

The gown was cleared by the FDA through a traditional 510(k) submission (K921157) and is classified under product code FYA. It is supplied as a single item identified by the item number 4942 and is subject to the regulatory conditions applicable to surgical gowns, including any sterility and single‑use requirements specified by the manufacturer.

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