510(k) K110979 ยท LZA Polymer Patient Examination Glove
DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS
| Applicant | Advanced Medical Products Sdn Bhd, Ayer Tawar, MY |
| Decision | Substantially Equivalent, Oct 20, 2011 |
| Received | Apr 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110979
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2015 | Cardinal Health Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use.
Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials a Terminated |
LZA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.