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Examination gloves – Type A (Latex gloves)
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · Model M · UDI-DI 16972267280321
1
510(k) clearances
2,992
Adverse events (17 deaths)
6
Recalls
150
Facilities
Description
Powder-free textured; The packages of proposed device including middle box package and outer carton package. Middle box package quantity: 100PCS Outer carton package quantity: 2000PCS
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-08-19 | Ansell Healthcare Products LLC | Examination gloves were shipped inadvertently, without to verify barrier integrity. |
| 2011-12-22 | Adenna Inc | The recall was initiated because Adenna Inc. distributed latex gloves that have been FDA refused. |
| 2006-04-10 | Gulf South Medical Supply Inc | FDA's laboratory analysis found holes in the gloves that exceeded the allowable limit. Gloves with holes compromise the integrity of the latex barrier and have the potential to all |
| 2003-06-27 | Henry Schein, Inc. | FDA's analysis revealed defects (holes) in the latex gloves. |
| 2003-06-27 | Henry Schein, Inc. | FDA's analysis revealed defects (holes) in the latex gloves. |
| 2002-07-23 | American Healthcare Products Inc | Unfit for intended use due to stickiness. |
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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.