Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hl Rubber Industries Sdn Bhd — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
151 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220545 | Powder Free Nitrile Examination Gloves, Blue, Tested for use | Hl Rubber Industries Sdn Bhd | 2022-05-26 | 90 | 0 |
| K141021 | POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR | Hl Rubber Industries Sdn Bhd | 2014-08-26 | 127 | 0 |
| K140316 | EXAMINATION GLOVES | Hl Rubber Industries Sdn Bhd | 2014-07-11 | 151 | 0 |
| K130038 | POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE | Hl Rubber Industries Sdn Bhd | 2013-02-21 | 45 | 0 |
| K100369 | POWDER-FREE NITRILE GLOVES, BLACK | Hl Rubber Industries Sdn Bhd | 2010-05-20 | 97 | 0 |
| K063522 | POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR) | Hl Rubber Industries Sdn Bhd | 2007-02-08 | 78 | 0 |
| K063524 | POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR | Hl Rubber Industries Sdn Bhd | 2007-01-23 | 62 | 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