HEPRO.US- Exam Class Latex Gloves Size X-Large - Case

Basic Information

• Brand Name: HEPRO.US- Exam Class Latex Gloves Size X-Large - Case
• Primary DI: 00854427007247
• Version / Model: CT - Latex Exam XL
• Company Name: HEPRO.US INC.
• Labeler DUNS: 080061451
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2017-06-21
• Public Version: 3
• Public Version Date: 2020-06-19
• Public Version Status: Update
• Public Device Record Key: 9049039b-f4cd-44cb-9ef9-18c1523293c0

Device Description

HEPRO.US- Exam Class Latex Gloves 100pcs per Box, 10 Boxes per Carton

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

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
Primary	00854427007247	GS1
Unit of Use	85442700724702	GS1