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Komfort SIM40/L

by Solid Wing Wholesale Inc.

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 Number00810054144823 UDI-DI Date4 Apr 2023ListedStatusListed 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  • Withdrawn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
Komfort
Generic Name
Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Model / Ref / Catalog
SIM40/L
Primary DI / UDI-DI
00810054144823
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

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

Cleared under the same submission (K112294)

Show all (12)

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Properties

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

Other properties (9)

  • 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