FDA Device Intelligence
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Polymer Patient Examination Glove

FDA product code LZA · Class 1 · General Hospital

9,700
Registered devices
635
Adverse events
7
Recalls
1,175
510(k) clearances

Devices with this code

Cranberry — ASCEND EAGLE INCORPORATEDGymda — Guangdong Gymda Medical Technology Co., Ltd.EUROPAPA — Europapa Handels GmbHBosma Enterprises — Bosma EnterprisesNitrilex Surpass gloves — SAFCO DENTAL SUPPLY CO.CareStock — MCKESSON MEDICAL-SURGICAL INC.NES EARTH AF POWDER FREE MEDICAL NITRILE EXAMINATION GLOVES — MAXILL, INC.Cypress — MCKESSON MEDICAL-SURGICAL INC.JMU — JMU DENTAL, INCRiverstone Resources — TECHNIGLOVE INTERNATIONAL, INC.DR. GREENPANDA — GREENPANDA SAFECARE INC.Get-A-Grip — SUMMIT GLOVE INC.Flextreme — P H & S PRODUCTS LLCMEDLINE — MEDLINE INDUSTRIES, INC.force black — Harps USA, Inc.MEDLINE — MEDLINE INDUSTRIES, INC.Miracle — ADENNA LLCEnSure — ECON DISPOSABLE SUPPLIES, INCCirrus — HOURGLASS INTERNATIONAL INCAMMEX Professional — AMMEX CORPORATIONMember's Mark — WAL-MART STORES, INC.Essentials by 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLCMedisca Safe-Sense — Medisca Inc.Miracle — ADENNA LLC

Recent 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

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.