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OmniTrustTM
OMNI INTERNATIONAL CORP. · Model 313-14 · UDI-DI 00810572000892
10
510(k) clearances
211
Adverse events
7
Recalls
132
Facilities
Description
Vinyl Examination Glove Powder Free X-Large
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. It is possible that c |
| 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 them for sale. |
| 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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Get your free API keyRead the docsData 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.