Skip to content

Convertors Sms Polyolefin Gown

by Allegiance Healthcare Corp.

510(k) K020593

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

7 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 · Special NumberK020593 Date18 Mar 2002ClearedStatusActive

Recalls

23 recalls · 7 ongoing · FDA

  • 7 recalls, same reason

    • Ongoing Z-0373-2022 FDA Class II initiated 2 Nov 2021
    • Ongoing Z-0377-2022 FDA Class II initiated 2 Nov 2021
    • Ongoing Z-0376-2022 FDA Class II initiated 2 Nov 2021
    • Ongoing Z-0374-2022 FDA Class II initiated 2 Nov 2021
    • Ongoing Z-0378-2022 FDA Class II initiated 2 Nov 2021
    • Ongoing Z-0372-2022 FDA Class II initiated 2 Nov 2021
    • Ongoing Z-0375-2022 FDA Class II initiated 2 Nov 2021

    Potential for open packaging seals compromising the sterility of the surgical gowns

  • 16 recalls, same reason

    • Terminated Z-1024-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1011-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1023-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1040-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1026-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1036-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1025-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1013-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1022-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1010-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1012-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1035-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1014-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1027-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1034-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1009-2020 FDA Class II initiated 11 Jan 2020

    The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

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  • Withdrawn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

Other devices from Allegiance Healthcare Corp.

See all devices from Allegiance Healthcare Corp. →