Careplus (M) Sdn Bhd · Class I · Cleared Jun 24, 2021
| K-number | K210656 |
| Device name | 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 |
| Applicant | Careplus (M) Sdn Bhd |
| Product code | KGO |
| Device class | Class I |
| Decision date | Jun 24, 2021 |
| Decision | Substantially Equivalent |
| Regulation | 878.4460 |
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