Careglove Global Sdn. Bhd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Careglove Global Sdn. Bhd.” (first 2017, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 196 days. Since 2017 the median was 196 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 |
|---|---|---|
| 2017 | 2 | 204 |
| 2018 | 0 | — |
| 2019 | 1 | 327 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 3 | 222 |
| 2023 | 1 | 118 |
| 2024 | 0 | — |
| 2025 | 1 | 33 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Careglove Global Sdn. Bhd. took a median 196 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 |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 6 | 6 |
| KGO | Surgeon'S Gloves | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Careglove Global Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250578 | Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) | LZA | 2025-04-01 | 33 |
| K230121 | Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) | LZA | 2023-05-15 | 118 |
| K220859 | Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) | LZA | 2022-09-09 | 169 |
| K213993 | Powder Free Chloroprene Examination Glove Coloured (Blue, Green) | LZA | 2022-08-05 | 227 |
| K211666 | Powder Free Nitrile Examination Gloves, Blue Chemotest | LZA | 2022-01-09 | 222 |
| K190241 | Sterile Latex Surgical Glove, Powder Free | KGO | 2019-12-30 | 327 |
| K172015 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) | LZA | 2017-09-26 | 85 |
| K161833 | LATEX EXAMINATION GLOVE POWDER FREE | LYY | 2017-05-23 | 322 |
Recalls
openFDA lists no recalls under a recalling firm named Careglove Global 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 Careglove Global Sdn. Bhd.?
FDA lists 8 510(k) clearances under the applicant name “Careglove Global Sdn. Bhd.” (first 2017, latest 2025), across 3 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 Careglove Global Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Careglove Global Sdn. Bhd. is 196 days. Since 2017: 196 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Careglove Global Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 6); KGO (Surgeon'S Gloves, 1); LYY (Latex Patient Examination Glove, 1).
Next steps
- See all 8 Careglove Global Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Careglove Global 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.