Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spi Gloves Sdn. Bhd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
16 daysmedian FDA review time
279 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050526 | POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GL | Spi Gloves Sdn. Bhd. | 2005-12-06 | 279 | 0 |
| K050528 | POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PI | Spi Gloves Sdn. Bhd. | 2005-05-19 | 78 | 0 |
| K050532 | CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI | Spi Gloves Sdn. Bhd. | 2005-04-14 | 43 | 0 |
| K050527 | POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAI | Spi Gloves Sdn. Bhd. | 2005-03-18 | 16 | 0 |
| K050531 | POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE) | Spi Gloves Sdn. Bhd. | 2005-03-18 | 16 | 0 |
| K050529 | POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PRO | Spi Gloves Sdn. Bhd. | 2005-03-16 | 14 | 0 |
| K050530 | POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE, | Spi Gloves Sdn. Bhd. | 2005-03-16 | 14 | 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