Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ultrawin Sdn Bhd · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
151 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090828 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES | Ultrawin Sdn Bhd | 2009-07-28 | 124 | 0 |
| K072802 | SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIEN | Ultrawin Sdn Bhd | 2008-02-29 | 151 | 0 |
| K992175 | EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POL | Ultrawin Sdn Bhd | 1999-09-24 | 88 | 0 |
| K983175 | EXTRA-CARE POWDER-FREE EXAMINATION GLOVE | Ultrawin Sdn Bhd | 1998-10-13 | 33 | 0 |
| K920059 | ULTRASAFE | Ultrawin Sdn Bhd | 1992-03-11 | 65 | 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