Careplus (M) Sdn Bhd
Negeri Sembilan Darul Khusus, MY
Careplus (M) Sdn Bhd appears in FDA device records in Negeri Sembilan Darul Khusus, MY. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Careplus (M) Sdn Bhd between 2015 and 2021. The busiest year on record is 2021, with 6. The most recent is 2021, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| 2021 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K211621 | Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) | KGO | Substantially Equivalent | |
| K203705 | Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) | LYY | Substantially Equivalent | |
| K201857 | Powder Free Nitrile Examination Glove Black and Dual Color White-Blue | LZA | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K162858 | NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST | LZC | Substantially Equivalent | |
| K152593 | LATEX EXAMINATION GLOVE POWDER FREE | LYY | Substantially Equivalent | |
| K142858 | POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored) | LZA | Substantially Equivalent | |
| K142862 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). | LZA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain