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Cardinal Health Non-Reinforced Surgical Gown

by Cardinal Health 200, LLC

510(k) K170762

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

17 closed

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 NumberK170762 Date9 Jun 2017ClearedStatusActive

Recalls

17 recalls · FDA

  • 17 recalls, same reason

    • Terminated Z-1020-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1039-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1029-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1037-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1003-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1028-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1007-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1016-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1015-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1030-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1021-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1018-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1031-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1019-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1032-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1033-2020 FDA Class II initiated 11 Jan 2020
    • Terminated Z-1038-2020 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  • Withdrawn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
FDA applicant
Cardinal Health200, LLC
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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