Careplus (M) Sdn Bhd · Class I · Cleared Aug 3, 2021
| K-number | K210724 |
| Device name | 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 |
| Applicant | Careplus (M) Sdn Bhd |
| Product code | KGO |
| Device class | Class I |
| Decision date | Aug 3, 2021 |
| Decision | Substantially Equivalent |
| Regulation | 878.4460 |
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