Careplus (M) Sdn Bhd
FDA 510(k) & PMA Approved Devices — 8 products
Total Devices8
Categories4
Latest FDA decision2021-10-06
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K211621 | Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) | KGO | 2021-10-06 | View |
| 510(k) | K203705 | Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) | LYY | 2021-08-20 | View |
| 510(k) | K201857 | Powder Free Nitrile Examination Glove Black and Dual Color White-Blue | LZA | 2021-08-20 | View |
| 510(k) | K210724 | ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs | KGO | 2021-08-03 | View |
| 510(k) | K210656 | ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs | KGO | 2021-06-24 | View |
| 510(k) | K202765 | ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs | KGO | 2021-05-27 | View |
| 510(k) | K162858 | NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST | LZC | 2017-07-24 | View |
| 510(k) | K152593 | LATEX EXAMINATION GLOVE POWDER FREE | LYY | 2016-02-25 | View |
No matching devices.