Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ssn Gloves (M) 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) |
|---|---|---|---|---|---|
| K012880 | STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR | Ssn Gloves (M) Sdn Bhd | 2001-11-16 | 80 | 0 |
| K012896 | STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING | Ssn Gloves (M) Sdn Bhd | 2001-11-16 | 80 | 0 |
| K990527 | KLEENHANDS POWDERED LATEX EXAMINATION GLOVES | Ssn Gloves (M) Sdn Bhd | 1999-04-23 | 63 | 0 |
| K990526 | KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN | Ssn Gloves (M) Sdn Bhd | 1999-04-23 | 63 | 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