Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shanghai PM Plastics Enterise Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
39 daysmedian FDA review time
307 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K024026 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE | Shanghai PM Plastics Enterise Co., Ltd. | 2002-12-18 | 12 | 0 |
| K002814 | DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLO | Shanghai PM Plastics Enterise Co., Ltd. | 2000-10-20 | 39 | 0 |
| K963797 | PM SYNTHETIC MEDICAL GLOVES, POWDER FREE | Shanghai PM Plastics Enterise Co., Ltd. | 1996-10-29 | 36 | 0 |
| K963514 | PACER PLUS SYNTHETIC MEDICAL VINLY PATIENT EXAMINATION GLOVE | Shanghai PM Plastics Enterise Co., Ltd. | 1996-10-24 | 51 | 0 |
| K930266 | VINYL EXAMINATION GLOVES | Shanghai PM Plastics Enterise Co., Ltd. | 1993-11-22 | 307 | 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