Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vietglove Corporation · 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) |
|---|---|---|---|---|---|
| K201428 | Powder Free Black Nitrile Examination Glove | Vietglove Corporation | 2021-06-24 | 391 | 0 |
| K170094 | POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED | Vietglove Corporation | 2017-06-23 | 163 | 0 |
| K162175 | Powder Free Latex Examination Glove with Protein Labeling Cl | Vietglove Corporation | 2016-11-21 | 110 | 0 |
| K153562 | Powder Free Blue Nitrile Examination Glove | Vietglove Corporation | 2016-04-01 | 109 | 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