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Aira 119201

by Aira, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810194400117 UDI-DI Date16 Jan 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Aira
Generic Name
Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Model / Reference
119201
Primary DI / UDI-DI
00810194400117
510(k) Number
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

Related devices

Cleared under the same submission (K172930)

Show all (12)

Other devices from Aira, LLC

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Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • 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