Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pm Gloves, Inc. · 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) |
|---|---|---|---|---|---|
| K905055 | PM GLOVE | Pm Gloves, Inc. | 1991-01-18 | 72 | 0 |
| K902670 | PM GLOVES (MFG: BJL GLOVE (M) SDN.BHD.) | Pm Gloves, Inc. | 1990-09-05 | 79 | 0 |
| K891356 | PATIENT EXAMINATION GLOVES (VINYL) | Pm Gloves, Inc. | 1989-04-13 | 34 | 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