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Halyard DNAZ037-03

by Medical Action Industries Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

9 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10809160539026 UDI-DI Date25 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

9 recalls · FDA

    • Terminated Z-0893-2017 FDA Class II initiated 24 Oct 2016

    Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove.

    • Terminated Z-0413-2010 FDA Unclassified (pre-2012) initiated 19 May 2009 on shared 510(k) K984558

    Surgical gloves in hospital convenience kits may be degraded and tear during use.

  • 7 recalls, same reason

    • Terminated Z-1588-2009 FDA Unclassified (pre-2012) initiated 1 May 2009
    • Terminated Z-1583-2009 FDA Unclassified (pre-2012) initiated 1 May 2009
    • Terminated Z-1586-2009 FDA Unclassified (pre-2012) initiated 1 May 2009
    • Terminated Z-1584-2009 FDA Unclassified (pre-2012) initiated 1 May 2009
    • Terminated Z-1589-2009 FDA Unclassified (pre-2012) initiated 1 May 2009
    • Terminated Z-1587-2009 FDA Unclassified (pre-2012) initiated 1 May 2009
    • Terminated Z-1585-2009 FDA Unclassified (pre-2012) initiated 1 May 2009

    Premature degradation which could result in tearing during use.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Halyard
Generic Name
Polychloroprene surgical glove, non-powdered
Model / Reference
DNAZ037-03
Primary DI / UDI-DI
10809160539026
510(k) Number
FDA Product Code
KGO
GMDN Term
Polychloroprene surgical glove, non-powdered
Device Class
Class I
Regulation Number
878.4460
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K984558)

Other devices from Medical Action Industries Inc.

See all devices from Medical Action Industries Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No