Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
P.T. Latexindo Prautama · 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) |
|---|---|---|---|---|---|
| K910631 | SUNTEX STERILE EXAM GLOVES | P.T. Latexindo Prautama | 1991-03-07 | 22 | 0 |
| K900296 | SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES | P.T. Latexindo Prautama | 1990-03-14 | 51 | 0 |
| K892478 | SAFETEX & SUNTEX PATIENT EXAMINATION GLOVES | P.T. Latexindo Prautama | 1989-05-08 | 31 | 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