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Sempermed Syntegra Green SGR800

by Harps USA, Inc. GUDID 2 variants

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09001570557438 UDI-DIDate12 Feb 2026ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Sempermed Syntegra Green
Generic Name
Polychloroprene surgical glove, non-powdered
Model / Ref / Catalog
SGR800
Primary DI / UDI-DI
09001570557438
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