Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hwa Teh Industrial Sdn. Bhd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
38 daysmedian FDA review time
56 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010803 | POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR | Hwa Teh Industrial Sdn. Bhd. | 2001-05-11 | 56 | 0 |
| K000725 | HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH P | Hwa Teh Industrial Sdn. Bhd. | 2000-04-05 | 30 | 0 |
| K994432 | HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEI | Hwa Teh Industrial Sdn. Bhd. | 2000-02-16 | 48 | 0 |
| K992810 | HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE | Hwa Teh Industrial Sdn. Bhd. | 1999-09-27 | 38 | 0 |
| K992730 | HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE | Hwa Teh Industrial Sdn. Bhd. | 1999-09-14 | 32 | 0 |
| K896251 | HWA TEH EXAMINATION GLOVES | Hwa Teh Industrial Sdn. Bhd. | 1989-11-21 | 22 | 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