Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Protection Gloves Sdn. Bhd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
105 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011231 | CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN | Protection Gloves Sdn. Bhd. | 2001-06-13 | 51 | 0 |
| K010854 | CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GRE | Protection Gloves Sdn. Bhd. | 2001-06-13 | 83 | 0 |
| K000668 | POWDER-FREE NON-VHLORINATED POLYMER COATED LATEX EXAMINATION | Protection Gloves Sdn. Bhd. | 2000-04-28 | 60 | 0 |
| K000667 | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAI | Protection Gloves Sdn. Bhd. | 2000-04-28 | 60 | 0 |
| K945164 | MULTIPLE | Protection Gloves Sdn. Bhd. | 1995-02-03 | 105 | 1 |
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