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Ambitex LXL800

by Tradex International, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00699320102152 UDI-DI Date22 Apr 2019ListedStatusListed GUDID: not 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  • Withdrawn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
Ambitex
Generic Name
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Model / Ref / Catalog
LXL800
Primary DI / UDI-DI
00699320102152
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
Not in Commercial Distribution

Properties

  • Single Use
  • Contains Latex
  • Over-the-Counter
  • Lot / Batch Number

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No