OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves

Basic Information

• Brand Name: OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves
• Primary DI: 00057565121176
• Version / Model: 012-117
• Company Name: A.M.G. Médicale Inc
• Labeler DUNS: 207372814
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-15
• Public Version: 1
• Public Version Date: 2020-09-23
• Public Version Status: New
• Public Device Record Key: b0547214-65d7-49df-91b1-8fc93ac64d87

Device Description

Customer focused packaging with attractive, easy to read boxes. Flexible packaging allowing vertical or horizontal merchandising increasing shop-ability while reducing shelf and storage space Ergonomic opening to avoid waste Recyclable packaging Comfortable fit Latex-free and powder-free for low allergy or dermatitis potential Beaded cuff to prevent roll-down Snug fit for good sensation and grip Meets or exceeds ASTM standards for Medical Exam gloves Ideal for use with chemicals that will compromise vinyl and latex gloves ASTM F1671 - Penetration by Blood-Borne Pathogens ASTM D6319 - Specification for Nitrile Examination Gloves for Medical Application Chemotherapy tested using ASTM D6978

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: No
• 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
LZA	Polymer Patient Examination Glove	General Hospital	880.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56286	Nitrile examination/treatment glove, non-powdered, non-antimicrobial	A device made of nitrile 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 and comfort of use, and should provide 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	10057565121173	GS1	Master Case	10	In Commercial Distribution
Primary	00057565121176	GS1

Premarket Submissions

Submission Number	Supplement Number
K110981	000