SemperShield CR Chloroprene Exam Glove

Basic Information

• Brand Name: SemperShield CR Chloroprene Exam Glove
• Primary DI: 00841277102987
• Version / Model: SSCR105
• Catalog Number: SSCR105
• Company Name: SEMPERMED USA, INC.
• Labeler DUNS: 004072158
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-01-01
• Public Version: 2
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: ac827a6b-7668-4427-a796-e0c296c78940

Device Description

SemperShield CR Chloroprene Exam Glove, size XL

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LZA	Polymer Patient Examination Glove	General Hospital	880.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56288	Polychloroprene examination/treatment glove, non-powdered	A device made of polychloroprene (neoprene) intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841277102987	GS1
Unit of Use	00841277103991	GS1

Customer Contacts

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