Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Careglove Global Sdn. Bhd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
222 daysmedian FDA review time
327 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250578 | Nitrile Examination Gloves Powder Free Tested for Use With C | Careglove Global Sdn. Bhd. | 2025-04-01 | 33 | 0 |
| K230121 | Nitrile Examination Gloves Powder Free Tested For Use With C | Careglove Global Sdn. Bhd. | 2023-05-15 | 118 | 0 |
| K220859 | Powder Free Nitrile Examination Gloves, Colored (Green, Oran | Careglove Global Sdn. Bhd. | 2022-09-09 | 169 | 0 |
| K213993 | Powder Free Chloroprene Examination Glove Coloured (Blue, Gr | Careglove Global Sdn. Bhd. | 2022-08-05 | 227 | 0 |
| K211666 | Powder Free Nitrile Examination Gloves, Blue Chemotest | Careglove Global Sdn. Bhd. | 2022-01-09 | 222 | 0 |
| K190241 | Sterile Latex Surgical Glove, Powder Free | Careglove Global Sdn. Bhd. | 2019-12-30 | 327 | 0 |
| K172015 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) | Careglove Global Sdn. Bhd. | 2017-09-26 | 85 | 0 |
| K161833 | LATEX EXAMINATION GLOVE POWDER FREE | Careglove Global Sdn. Bhd. | 2017-05-23 | 322 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda