Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hong Seng Gloves 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) |
|---|---|---|---|---|---|
| K221164 | Powder Free Nitrile Examination Glove - Blue, Non-Sterile, T | Hong Seng Gloves Sdn Bhd | 2022-08-30 | 130 | 0 |
| K212801 | Powder free nitrile examination glove- black, non sterile | Hong Seng Gloves Sdn Bhd | 2022-01-09 | 129 | 0 |
| K212802 | powder free nitrile examination glove - white, non-sterile | Hong Seng Gloves Sdn Bhd | 2021-12-02 | 91 | 0 |
| K212804 | Powder free nitrile examination glove- blue, non-sterile | Hong Seng Gloves Sdn Bhd | 2021-12-01 | 90 | 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