Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Summit Glove, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
228 daysmedian FDA review time
266 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220371 | Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambi | Summit Glove, Inc. | 2022-11-02 | 266 | 0 |
| K220373 | Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamo | Summit Glove, Inc. | 2022-04-13 | 63 | 0 |
| K220375 | Intercept Free, Nitrile Two Toned White/Green, Textured Fing | Summit Glove, Inc. | 2022-04-13 | 63 | 0 |
| K093516 | NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NIT | Summit Glove, Inc. | 2010-06-29 | 228 | 0 |
| K093517 | NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE | Summit Glove, Inc. | 2010-06-29 | 228 | 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