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SurgiMac 6116-XL-Case

by Surgimac LLC

SurgiMac 6116-XL-Case is a Class I device made by Surgimac LLC, listed in FDA GUDID since 20 Nov 2023 (UDI-DI DXL6116CASE3000), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberDXL6116CASE3000 UDI-DI Date20 Nov 2023ListedStatusListed 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  • Withdrawn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
SurgiMac
Generic name
Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Model / reference
6116-XL-Case
Primary DI / UDI-DI
DXL6116CASE3000
FDA product code
OPJ
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
  • Expiration date
  • Manufacturing date
Other properties (12, all answered No)