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Smile 300 Blue Nitrile Examination Gloves B8350

by Top Quality Manufacturing, Inc.

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 NumberTQ26B83501 UDI-DI Date11 Dec 2024ListedStatusListed 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  • Withdrawn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
Smile 300 Blue Nitrile Examination Gloves
Generic Name
Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Model / Reference
B8350
Description
Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size XL
Primary DI / UDI-DI
TQ26B83501
FDA Product Code
LZA, LZC
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

Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Other devices from Top Quality Manufacturing, Inc.

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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