Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
P.T. Latexindo Tobaperkasa · 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) |
|---|---|---|---|---|---|
| K974442 | PRE-POWDERED NITRILE EXAMINATION GLOVES | P.T. Latexindo Tobaperkasa | 1998-01-05 | 41 | 0 |
| K974443 | POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED | P.T. Latexindo Tobaperkasa | 1998-01-05 | 41 | 0 |
| K972539 | Hi Coat Powder Free Latex Patient Examination Gloves | P.T. Latexindo Tobaperkasa | 1997-11-18 | 133 | 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