510(k) K002064 ยท LZA Polymer Patient Examination Glove
COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL
| Applicant | Wrp Asia Pacific Sdn. Bhd., Salak Tinggi, Sepang Selangor, MY |
| Decision | Substantially Equivalent, Nov 28, 2000 |
| Received | Jul 7, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002064
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2021 | Cardinal Health 200, LLC Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K Terminated |
LYU | None listed |
| Jan 7, 2021 | Cardinal Health 200, LLC CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K Terminated |
LYU | None listed |
| Jan 7, 2021 | Cardinal Health 200, LLC ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K Terminated |
LYU | None listed |
| Mar 22, 2019 | Cardinal Health 200, LLC ChemoPlus Chemo Spill Kit
Product Code:CT4004
Product Usage:
ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills Terminated |
LZA | None listed |
| Mar 22, 2019 | Cardinal Health 200, LLC ChemoPlus Chemo Spill Kit
Product Code:DP5016K
Product Usage:
ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills Terminated |
LZA | None listed |
| Mar 22, 2019 | Cardinal Health 200, LLC ChemoPlus Protective Wrap-around Goggles
Product Code:DP5030G
Product Usage:
ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills Terminated |
LZA | None listed |
| Mar 22, 2019 | Cardinal Health 200, LLC ChemoPlus Chemo Spill Kit, Home Health Kit
Product Code:DP5108K
Product Usage:
ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills Terminated |
LZA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.