Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Profit Point Manufacturing Sdn Bhd · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120110 | ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET | Profit Point Manufacturing Sdn Bhd | 2012-10-04 | 265 | 0 |
| K101760 | ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION G | Profit Point Manufacturing Sdn Bhd | 2010-10-06 | 105 | 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