Sempermed Syntegra Green

Basic Information

• Brand Name: Sempermed Syntegra Green
• Primary DI: 09001570536709
• Version / Model: SGR650
• Catalog Number: SGR650
• Company Name: Harps USA, Inc.
• Labeler DUNS: 004072158
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2025-12-12
• Public Version: 1
• Public Version Date: 2025-12-22
• Public Version Status: New
• Public Device Record Key: a2065260-f8dd-4738-9750-4f55e51578b6
• Distribution End Date: 2025-12-12

Device Description

Polyisoprene Surgical Glove PF - 6.5

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGO	Surgeon'S Gloves	General, Plastic Surgery	878.4460	1
LZC	Medical Glove, Specialty	General Hospital	880.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57970	Polychloroprene surgical glove, non-powdered	A device made of polychloroprene (neoprene) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00841277110814	GS1
Primary	09001570536709	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K250313	000