Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bettercare Plastic Products Co., Ltd. · 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) |
|---|---|---|---|---|---|
| K092302 | POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VER | Bettercare Plastic Products Co., Ltd. | 2010-05-05 | 280 | 0 |
| K092301 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE | Bettercare Plastic Products Co., Ltd. | 2009-10-22 | 85 | 0 |
| K092296 | POWDER FREE EXAMINATION GLOVE | Bettercare Plastic Products Co., Ltd. | 2009-10-21 | 84 | 0 |
| K092294 | VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR | Bettercare Plastic Products Co., Ltd. | 2009-10-21 | 84 | 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