Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Pro Latex, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
164 daysmedian FDA review time
446 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962539 | GANTEX MODEL NSG-75PF | American Pro Latex, Inc. | 1997-07-14 | 381 | 0 |
| K953358 | SURGEONS GLOVE POWDER FREE | American Pro Latex, Inc. | 1995-12-28 | 164 | 0 |
| K915157 | POWDER FREE EXAMINATION GLOVE | American Pro Latex, Inc. | 1993-02-02 | 446 | 0 |
| K910711 | AMPRO SURGEON'S GLOVES | American Pro Latex, Inc. | 1991-03-29 | 37 | 0 |
| K904740 | AMPRO LATEX EXAM GLOVE | American Pro Latex, Inc. | 1990-10-26 | 8 | 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