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Guardian 16-100SM

by Icp, 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 NumberD77116100SM1 UDI-DI Date19 Mar 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  • Withdrawn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
Guardian
Generic name
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Model / reference
16-100SM
Primary DI / UDI-DI
D77116100SM1
FDA product code
LYY
GMDN term
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Device class
Class I
Regulation number
880.6250
GUDID distribution status
In Commercial Distribution

Other devices from Icp, Inc.

See all devices from Icp, Inc. →

Properties

  • Single use
  • Contains latex
  • Over-the-counter
  • Lot / batch number
  • Manufacturing date

Other properties (10)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Prescription use: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No