FDA Device Intelligence
Home › HENRY SCHEIN, INC. › Criterion Nitrile EC

Criterion Nitrile EC

HENRY SCHEIN, INC. · Model 1126788 · UDI-DI 10304040101701

LZALZC
10
510(k) clearances
706
Adverse events
10
Recalls
383
Facilities

Description

Criterion Nitrile EC LARGE

Recalls

DateFirmReason
2026-08-14American Nitrile Operations LlcGloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading
2026-08-14American Nitrile Operations LlcGloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading
2026-08-14American Nitrile Operations LlcGloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading
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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.