Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Top Quality Mfg., Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013821 | SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CON | Top Quality Mfg., Inc. | 2002-03-05 | 109 | 0 |
| K013254 | POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & P | Top Quality Mfg., Inc. | 2002-02-04 | 129 | 0 |
| K004018 | SKINGARD POLYCOAT GLOVE | Top Quality Mfg., Inc. | 2001-05-11 | 135 | 0 |
| K000050 | TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES | Top Quality Mfg., Inc. | 2000-07-27 | 202 | 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