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Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating

by Cardinal Health, Medical Products and Services

510(k) K113707

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 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 NumberK113707 Date27 Apr 2012ClearedStatusActive

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-0637-2019 FDA Class II initiated 31 Oct 2018
    • Terminated Z-0631-2019 FDA Class II initiated 31 Oct 2018
    • Terminated Z-0636-2019 FDA Class II initiated 31 Oct 2018
    • Terminated Z-0634-2019 FDA Class II initiated 31 Oct 2018
    • Terminated Z-0633-2019 FDA Class II initiated 31 Oct 2018
    • Terminated Z-0635-2019 FDA Class II initiated 31 Oct 2018
    • Terminated Z-0632-2019 FDA Class II initiated 31 Oct 2018
    • Terminated Z-0638-2019 FDA Class II initiated 31 Oct 2018

    Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.

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  • Withdrawn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
KGO
FDA applicant
Cardinal Health-Medical Products and Services
Device Class
Class I
Regulation
21 CFR Part 878.4460
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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