510(k) K191800 ยท LZA Polymer Patient Examination Glove
Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim
| Applicant | Kossan International Sdn Bhd, Klang, MY |
| Decision | Substantially Equivalent, Sep 16, 2019 |
| Received | Jul 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191800
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.