Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aspen Glove 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) |
|---|---|---|---|---|---|
| K213076 | AspenMed+ | Aspen Glove Sdn. Bhd. | 2021-12-20 | 88 | 0 |
| K211477 | Latex Examination Powder Free Gloves | Aspen Glove Sdn. Bhd. | 2021-09-20 | 131 | 0 |
| K211479 | Blue Nitrile Examination Glove Powder Free | Aspen Glove Sdn. Bhd. | 2021-09-16 | 127 | 0 |
| K211478 | Sterile Latex Surgical Gloves Powder Free | Aspen Glove Sdn. Bhd. | 2021-09-16 | 127 | 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