Sempermed Syntegra IR Polyisoprene Surgical Glove

Basic Information

• Brand Name: Sempermed Syntegra IR Polyisoprene Surgical Glove
• Primary DI: 00841277106305
• Version / Model: SIR650
• Catalog Number: SIR650
• Company Name: SEMPERMED USA, INC.
• Labeler DUNS: 004072158
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-04-22
• Public Version: 1
• Public Version Date: 2022-05-02
• Public Version Status: New
• Public Device Record Key: 045b1683-b0c2-485e-b6f6-061489d501c4

Device Description

Sempermed Syntegra IR Polyisoprene Surgical Glove, size 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
OPA	Powder-Free Non-Natural Rubber Latex Surgeon'S Gloves
KGO	Surgeon'S Gloves	General, Plastic Surgery	878.4460	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56293	Polyisoprene surgical glove, non-powdered, non-antimicrobial	A device made of polyisoprene 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
Package	10841277106302	GS1		6	In Commercial Distribution
Primary	00841277106305	GS1
Unit of Use	00841277106756	GS1

Customer Contacts

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