Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pt. Mandiri Inti Buana · 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) |
|---|---|---|---|---|---|
| K051987 | FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FR | Pt. Mandiri Inti Buana | 2005-10-06 | 76 | 0 |
| K042239 | FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERIL | Pt. Mandiri Inti Buana | 2004-12-16 | 120 | 0 |
| K031754 | FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE | Pt. Mandiri Inti Buana | 2003-06-30 | 91 | 0 |
| K031020 | FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE | Pt. Mandiri Inti Buana | 2003-05-21 | 51 | 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