Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Flexitech Sdn. Bhd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
44 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K994416 | POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | Flexitech Sdn. Bhd. | 2000-02-03 | 36 | 0 |
| K994354 | POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH P | Flexitech Sdn. Bhd. | 2000-01-31 | 39 | 0 |
| K990499 | PREPOWDERED NITRILE EXAMINATION GLOVES | Flexitech Sdn. Bhd. | 1999-04-02 | 44 | 0 |
| K990501 | POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CL | Flexitech Sdn. Bhd. | 1999-04-02 | 44 | 0 |
| K990495 | POWDER FREE NITRILE EXAMINATION GLOVES | Flexitech Sdn. Bhd. | 1999-04-02 | 44 | 0 |
| K990502 | PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LA | Flexitech Sdn. Bhd. | 1999-04-02 | 44 | 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