Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pt. Sarana Indoprotex · 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) |
|---|---|---|---|---|---|
| K980605 | LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE) | Pt. Sarana Indoprotex | 1998-04-14 | 56 | 0 |
| K970773 | POWDER-FREE EXAM GLOVES | Pt. Sarana Indoprotex | 1997-12-04 | 275 | 0 |
| K950823 | ANDAL | Pt. Sarana Indoprotex | 1995-05-10 | 76 | 0 |
| K913531 | PATIENT EXAMINATION GLOVEWS | Pt. Sarana Indoprotex | 1992-01-07 | 152 | 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