Sterigluv Singles

Basic Information

• Brand Name: Sterigluv Singles
• Primary DI: 00898110000412
• Version / Model: MGSE100M
• Catalog Number: MGSE100M
• Company Name: Medgluv Inc.
• Labeler DUNS: 015809044
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-10-31
• Public Version: 1
• Public Version Date: 2023-11-08
• Public Version Status: New
• Public Device Record Key: 8341a101-6884-47a4-8654-6072e8a23130

Device Description

Sterigluv Latex Exam Gloves, Sterile Singles, Medium

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYY	Latex patient examination glove	General Hospital	880.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47172	Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial	A device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. 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
Package	00898110000580	GS1	100ea/bx, 4bx/cs	4	In Commercial Distribution
Primary	00898110000412	GS1
Unit of Use	00810145951699	GS1

Customer Contacts

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