Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Safeskin Retailing (Hk) Limited · 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) |
|---|---|---|---|---|---|
| K222713 | White Nitrile Powder Free Patient Examination Glove, Non Ste | Safeskin Retailing (Hk) Limited | 2022-12-03 | 86 | 0 |
| K222715 | Black Nitrile Powder Free Patient Examination Glove, Non Ste | Safeskin Retailing (Hk) Limited | 2022-12-03 | 86 | 0 |
| K222720 | Blue Nitrile Powder Free Patient Examination Glove, Non Ster | Safeskin Retailing (Hk) Limited | 2022-12-03 | 86 | 0 |
| K222721 | Violet Nitrile Powder Free Patient Examination Glove, Non St | Safeskin Retailing (Hk) Limited | 2022-10-18 | 40 | 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