Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Teh Loong Corp. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052635 | TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVE | Teh Loong Corp. | 2005-12-13 | 78 | 0 |
| K052636 | TEH LOONG POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GL | Teh Loong Corp. | 2005-11-10 | 45 | 0 |
| K052634 | TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVE | Teh Loong Corp. | 2005-10-11 | 15 | 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