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First Aid Only

Acme United Corporation · Model 21-2600 · UDI-DI 00738743001052

LZA

510(k) clearances

635

Adverse events

Recalls

380

Facilities

Description

Nitrile exam gloves, Large 50/box

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.