Home › Device types › LYZ
Vinyl Patient Examination Glove
FDA product code LYZ · Class 1 · General Hospital
1,325
Registered devices
256
Adverse events
7
Recalls
799
510(k) clearances
Devices with this code
Strong Manufacturers — Strong Medical Partners LLCMedicom AssureTouch Shield — AMD Medicom IncBest Care — Meddcare CorporationProCure — Twin Med, LLCBASIC — Intco Medical Industries, Inc.HCS — Concordance Healthcare Solutions LLCAMMEX Professional — AMMEX CORPORATIONSafeHealth — PM GLOVES U S A INCMedicom AssureTouch Shield — AMD Medicom IncAdenna — ADENNA LLCGloves — GERI-GENTLE CORPORATIONGentleCath Hydrophilic Kit — Wellspect ABBYTECH — ANHUI BYTECH MEDICAL SUPPLIES CO., LTD.BASIC — Intco Medical Industries, Inc.Shamrock — Shamrock Marketing Co., Inc.PrimaPro — PRIMARY PRODUCTS COMPANYPRIMESOURCE — Bunzl USA Holdings LLCUP&UP — TARGET CORPORATIONMcKesson — MCKESSON MEDICAL-SURGICAL INC.GentleCath Hydrophilic Kit — Wellspect ABMEDHANDLER — Foodhandler Inc.NA — IMPACT PRODUCTS, LLCSimPro™ Set — Wellspect ABADI Medical — ADI Medical
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-07-02 | Cypress Medical Products LLC | The firm is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because a sample of product from that lot did not meet certain release specifications. I |
| 2016-10-12 | CYPRESS MEDICAL PRODUCTS | A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed. |
| 2012-06-20 | Gulf South Medical Supply Inc | Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing t |
| 2011-11-15 | Cypress Medical Products LLC | The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects. |
| 2011-11-15 | Cypress Medical Products LLC | The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects. |
| 2011-11-15 | Cypress Medical Products LLC | The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects. |
| 2009-04-30 | Kimberly-Clark Corporation | The product may contain defects/holes reducing the product's effectiveness as a barrier. |
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