Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Platinum Glove Industries Sdn. Bhd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
362 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182089 | Powder Free Blue Nitrile Examination Gloves - Tested for Use | Platinum Glove Industries Sdn. Bhd. | 2019-07-30 | 362 | 0 |
| K091965 | POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SC | Platinum Glove Industries Sdn. Bhd. | 2009-11-24 | 146 | 0 |
| K080165 | SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WH | Platinum Glove Industries Sdn. Bhd. | 2008-05-14 | 112 | 0 |
| K051372 | POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENT | Platinum Glove Industries Sdn. Bhd. | 2005-07-07 | 42 | 0 |
| K051317 | POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, | Platinum Glove Industries Sdn. Bhd. | 2005-06-20 | 31 | 0 |
| K051318 | POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PUR | Platinum Glove Industries Sdn. Bhd. | 2005-06-17 | 28 | 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