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Sempermed Syntegra Green SGR600

by Harps USA, Inc. 2 variants

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09001570557308 UDI-DIDate21 May 2026ListedStatusListed 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  • Withdrawn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
Sempermed Syntegra Green
Generic Name
Polychloroprene surgical glove, non-powdered
Model / Ref / Catalog
SGR600
Primary DI / UDI-DI
09001570557308
510(k) Number
FDA Product Code
KGO, LZC
GMDN Term
Polychloroprene surgical glove, non-powdered
Device Class
Class I
Regulation Number
878.4460, 880.6250
GUDID distribution status
Not in Commercial Distribution

Other devices from Harps USA, Inc.

See all devices from Harps USA, Inc. →

Properties

  • Sterile
  • Single Use
  • Over-the-Counter

Other properties (11)

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