Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
P.T. Saptindo Surgica · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031669 | STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER CO | P.T. Saptindo Surgica | 2003-09-23 | 117 | 0 |
| K031670 | STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATIN | P.T. Saptindo Surgica | 2003-09-23 | 117 | 0 |
| K945363 | MEDI PLUS SURGEON'S GLOVES | P.T. Saptindo Surgica | 1995-03-07 | 139 | 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