Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Super Safe Plastic Products Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
79 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070038 | POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW | Super Safe Plastic Products Co., Ltd. | 2007-03-23 | 79 | 0 |
| K070042 | POWDERED VINYL PATIENT EXAMINATION GLOVES, YELLOW | Super Safe Plastic Products Co., Ltd. | 2007-02-23 | 51 | 0 |
| K070030 | POWDER FREE VINYL PATIENT EXAMINATION GLOVE | Super Safe Plastic Products Co., Ltd. | 2007-02-16 | 44 | 0 |
| K070043 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE | Super Safe Plastic Products Co., Ltd. | 2007-02-08 | 36 | 0 |
| K070040 | POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE | Super Safe Plastic Products Co., Ltd. | 2007-01-26 | 23 | 0 |
| K070035 | POWDERED VINYL PATIENT EXAMINATION GLOVE | Super Safe Plastic Products Co., Ltd. | 2007-01-23 | 20 | 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