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Careplus (M) Sdn Bhd FDA Approvals
0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)510(k)Oct 6, 2021General, Plastic Surgery |
| Powder Free Nitrile Examination Glove Black and Dual Color White-Blue510(k)Aug 20, 2021General Hospital |
| Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)510(k)Aug 20, 2021General Hospital |
| 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 drugs510(k)Aug 3, 2021General, Plastic Surgery |
| 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 drugs510(k)Jun 24, 2021General, Plastic Surgery |
| ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs510(k)May 27, 2021General, Plastic Surgery |