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OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves by MedPro

A.M.G. Médicale Inc · Model 012-137 · UDI-DI 00057565121374

LZA

510(k) clearances

706

Adverse events

Recalls

380

Facilities

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

Recalls

Date	Firm	Reason
2020-10-23	HUBO INTERNATIONAL INC	Package labeled as nitrile gloves, contains latex gloves.
2019-03-22	Cardinal Health 200, LLC	Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
2019-03-22	Cardinal Health 200, LLC	Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
2019-03-22	Cardinal Health 200, LLC	Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
2019-03-22	Cardinal Health 200, LLC	Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
2016-11-10	Halyard Health	Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.
2015-08-25	Cardinal Health	Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufact

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.