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MacSoft 4116-M-CS

by Surgimac LLC

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD1054116MCS1 UDI-DI Date7 Aug 2025ListedStatusListed 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  • Withdrawn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
MacSoft
Generic name
Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Model / reference
4116-M-CS
Primary DI / UDI-DI
D1054116MCS1
FDA product code
LZA, LZC, QDO
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 Surgimac LLC

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Properties

  • Single use
  • Contains latex
  • Expiration date
  • Manufacturing date

Other properties (11)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Lot / batch number: No
  • Serial number: No