Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Contract Latex Dippers Sdn Bhd · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
191 daysmedian FDA review time
281 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011012 | POWDER FREE NITRILE EXAMINATION GLOVE | Contract Latex Dippers Sdn Bhd | 2001-05-01 | 27 | 0 |
| K983568 | OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM | Contract Latex Dippers Sdn Bhd | 1998-12-21 | 69 | 0 |
| K955947 | OSTAR EXAMINATION GLOVES | Contract Latex Dippers Sdn Bhd | 1996-06-10 | 195 | 0 |
| K954063 | GLOVE SEAL & SET-RITE | Contract Latex Dippers Sdn Bhd | 1996-06-05 | 281 | 0 |
| K934316 | GLOVE SEAL, POWDER FREE LATEX EXAMINATION GLOVES | Contract Latex Dippers Sdn Bhd | 1994-03-11 | 191 | 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