Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Betel Care Sdn. Bhd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222342 | Betel Gloves Nitrile Examination Glove Powder Free | Betel Care Sdn. Bhd. | 2022-09-24 | 52 | 0 |
| K073299 | BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE | Betel Care Sdn. Bhd. | 2008-03-05 | 103 | 0 |
| K000650 | BETEL POWDER FREE LATEX EXAM GLOVES | Betel Care Sdn. Bhd. | 2000-04-20 | 52 | 0 |
| K000652 | BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTE | Betel Care Sdn. Bhd. | 2000-04-10 | 42 | 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