FDA Device Intelligence
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Vinyl Patient Examination Glove

FDA product code LYZ · Class 1 · General Hospital

1,266
Registered devices
211
Adverse events
7
Recalls
799
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2018-07-02Cypress Medical Products LLCThe 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
2016-10-12CYPRESS MEDICAL PRODUCTSA container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.
2012-06-20Gulf South Medical Supply IncGulf 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
2011-11-15Cypress Medical Products LLCThe gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
2011-11-15Cypress Medical Products LLCThe gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
2011-11-15Cypress Medical Products LLCThe gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
2009-04-30Kimberly-Clark CorporationThe product may contain defects/holes reducing the product's effectiveness as a barrier.

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