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Owell OWNG4MBLUS-100

by Owell

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00850015109126 UDI-DI Date28 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Owell
Generic Name
Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Model / Reference
OWNG4MBLUS-100
Primary DI / UDI-DI
00850015109126
FDA Product Code
LZA
GMDN Term
Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Device Class
Class I
Regulation Number
880.6250
GUDID distribution status
In Commercial Distribution

Other devices from Owell

See all devices from Owell →

Properties

  • Single Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

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