Careplus (M) Sdn Bhd: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Careplus (M) Sdn Bhd” (first 2015, latest 2021), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 157 days. Since 2017 the median was 245 days, against 118 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 2 | 119 |
| 2016 | 1 | 168 |
| 2017 | 1 | 285 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 6 | 196 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Careplus (M) Sdn Bhd took a median 245 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 4 | 4 |
| LZA | Polymer Patient Examination Glove | 3 | 3 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (10)
Most recent Careplus (M) Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211621 | Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) | KGO | 2021-10-06 | 133 |
| K203705 | Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) | LYY | 2021-08-20 | 245 |
| K201857 | Powder Free Nitrile Examination Glove Black and Dual Color White-Blue | LZA | 2021-08-20 | 410 |
| 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 | 146 |
| 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 | 112 |
| 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 | 248 |
| K162858 | NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST | LZC | 2017-07-24 | 285 |
| K152593 | LATEX EXAMINATION GLOVE POWDER FREE | LYY | 2016-02-25 | 168 |
| K142858 | POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored) | LZA | 2015-02-09 | 131 |
| K142862 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). | LZA | 2015-01-16 | 107 |
Recalls
openFDA lists no recalls under a recalling firm named Careplus (M) Sdn Bhd.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Careplus (M) Sdn Bhd?
FDA lists 10 510(k) clearances under the applicant name “Careplus (M) Sdn Bhd” (first 2015, latest 2021), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Careplus (M) Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Careplus (M) Sdn Bhd is 157 days. Since 2017: 245 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Careplus (M) Sdn Bhd?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 4); LZA (Polymer Patient Examination Glove, 3); LYY (Latex Patient Examination Glove, 2).
Next steps
- See all 10 Careplus (M) Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code KGO, Careplus (M) Sdn Bhd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.