FDA Device Intelligence
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Medical Glove, Specialty

FDA product code LZC · Class 1 · General Hospital

3,644
Registered devices
78
Adverse events
8
Recalls
79
510(k) clearances

Devices with this code

Gymda — Guangdong Gymda Medical Technology Co., Ltd.EUROPAPA — Europapa Handels GmbHBosma Enterprises — Bosma EnterprisesCareStock — MCKESSON MEDICAL-SURGICAL INC.Get-A-Grip — SUMMIT GLOVE INC.EnSure — ECON DISPOSABLE SUPPLIES, INCCirrus — HOURGLASS INTERNATIONAL INCAMMEX Professional — AMMEX CORPORATIONMICRO-TOUCH — Ansell Healthcare ProductMedisca Safe-Sense — Medisca Inc.SurgiMac — Surgimac LLCCARDINAL HEALTH — Cardinal Health 200, LLCVentyv — SRI TRANG USA, INC.Medisca Safe-Sense — Medisca Inc.Sri Trang Gloves Viva Chemo Plus — SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITEDEagle Derma2 Nitrile Examination Gloves — Eagle Protect PbcBASIC — Intco Medical Industries, Inc.Home Green Leaf — UNIWARE HOUSEWARE CORP.REVOSOFT CT — CRANBERRY INTERNATIONAL SDN. BHD.BASIC — Intco Medical Industries, Inc.UltiMates — Shepard Medical Products, Inc.Scion — HOURGLASS INTERNATIONAL INCMerit Black Ntrile Examination Gloes Powder Free — Amercareroyal, LLCMacFit — Surgimac LLC

Recent recalls

DateFirmReason
2026-04-13O&M HALYARD INCNitrile Exam Glove failed to meet specifications chemical permeation performance.
2024-05-13SVS LLCFirm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled
2021-09-27O&M HALYARD INCAll lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.
2011-08-04Ansell Healthcare Products LLCGloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
2011-08-04Ansell Healthcare Products LLCGloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
2011-08-04Ansell Healthcare Products LLCGloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
2011-08-04Ansell Healthcare Products LLCGloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
2008-07-07Integra Pain ManagementRadiation reduction gloves were labeled as "Latex-free", but contain natural rubber latex.

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