Saf-Care

Basic Information

• Brand Name: Saf-Care
• Primary DI: 10857420007532
• Version / Model: SC204
• Company Name: ECON DISPOSABLE SUPPLIES, INC
• Labeler DUNS: 018198668
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2021-09-29
• Public Version: 1
• Public Version Date: 2021-10-07
• Public Version Status: New
• Public Device Record Key: 9efccf63-4374-41d8-b941-bbd93ed7404a

Device Description

Latex Powder Free Examination Gloves, XL

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
Unit of Use	00857420007535	GS1
Primary	10857420007532	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.