510(k) K220375 ยท LZA Polymer Patient Examination Glove
Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
| Applicant | Summit Glove, Inc., Minerva OH, US |
| Decision | Substantially Equivalent, Apr 13, 2022 |
| Received | Feb 9, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220375
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.