OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves

GUDID 00057565120971

Blue, Extra Small Packed: 100 / Box, 10 boxes / case Customer focused packaging 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

A.M.G. Médicale Inc

Nitrile examination/treatment glove, non-powdered, non-sterile

• Primary Device ID: 00057565120971
• NIH Device Record Key: c271d737-7977-4b95-bc7a-188694c33634
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves
• Version Model Number: 012-097
• Company DUNS: 207372814
• Company Name: A.M.G. Médicale Inc
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00057565120971 [Unit of Use]
GS1	00057565972389 [Package]; Contains: 05756512097148; Package: Case [10 Units]; In Commercial Distribution
GS1	05756512097148 [Primary]
GS1	10057565120978 [Package]; Package: Master Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110981

FDA Product Code

• LZA: Polymer Patient Examination Glove

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-13
• Device Publish Date: 2020-03-05

On-Brand Devices [OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves]

• 00057565120971: Blue, Extra Small Packed: 100 / Box, 10 boxes / case Customer focused packaging Attractive, easy
• 10057565121173: Customer focused packaging with attractive, easy to read boxes. Flexible packaging allowing vert