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Dermadel EC

Medzah Industries · Model DDMD05-EC · UDI-DI 10860011917455

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10
510(k) clearances
635
Adverse events
7
Recalls
380
Facilities

Description

Dermadel EC Nitrile Powder Free Exam Gloves, Blue, 12in, Finger 7.5mil, Palm 5.5mil, Textured Fingertip, Chemo, Fentanyl & Gastric Acid Approved, Accelerator Free, X-Large, 100/bx, 10bx/cs

Recalls

DateFirmReason
2020-10-23HUBO INTERNATIONAL INCPackage labeled as nitrile gloves, contains latex gloves.
2019-03-22Cardinal Health 200, LLCKit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
2019-03-22Cardinal Health 200, LLCKit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
2019-03-22Cardinal Health 200, LLCKit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
2019-03-22Cardinal Health 200, LLCKit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
2016-11-10Halyard HealthDefects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.
2015-08-25Cardinal HealthAmbitex 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.