Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zhonghong Pulin Medical Products Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
170 daysmedian FDA review time
230 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231029 | Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs A | Zhonghong Pulin Medical Products Co., Ltd. | 2023-10-30 | 202 | 0 |
| K230662 | Nitrile Exam Glove, Extended cuff, Tested For Use With Chemo | Zhonghong Pulin Medical Products Co., Ltd. | 2023-10-26 | 230 | 0 |
| K210460 | NitriTec Vinyl Glove Powder Free Blue | Zhonghong Pulin Medical Products Co., Ltd. | 2021-05-17 | 90 | 0 |
| K171873 | Powder Free Nitrile Patient Examination Glove, Blue Colored, | Zhonghong Pulin Medical Products Co., Ltd. | 2017-11-15 | 145 | 0 |
| K152712 | Nitrile Powder Free Patient Examination Gloves, Blue Color | Zhonghong Pulin Medical Products Co., Ltd. | 2016-03-09 | 170 | 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