Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shanghai PT Plastics Enterprise Company, Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
283 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022087 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE | Shanghai PT Plastics Enterprise Company, Ltd. | 2002-07-11 | 14 | 0 |
| K002870 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE CO | Shanghai PT Plastics Enterprise Company, Ltd. | 2000-10-16 | 33 | 0 |
| K001611 | DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE | Shanghai PT Plastics Enterprise Company, Ltd. | 2000-06-30 | 36 | 0 |
| K001601 | DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES | Shanghai PT Plastics Enterprise Company, Ltd. | 2000-06-23 | 30 | 0 |
| K961521 | PATIENT EXAMINATION GLOVE | Shanghai PT Plastics Enterprise Company, Ltd. | 1997-01-30 | 283 | 0 |
| K963751 | PT SYNTHETIC MEDICAL GLOVES, POWDER FREE | Shanghai PT Plastics Enterprise Company, Ltd. | 1996-10-29 | 41 | 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