Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shijiazhuang Hongray Plastic Products Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
93 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K994206 | SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GL | Shijiazhuang Hongray Plastic Products Co., Ltd. | 2000-02-07 | 55 | 0 |
| K994222 | SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION | Shijiazhuang Hongray Plastic Products Co., Ltd. | 2000-02-07 | 54 | 0 |
| K992922 | SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION G | Shijiazhuang Hongray Plastic Products Co., Ltd. | 1999-10-06 | 37 | 0 |
| K992860 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, W | Shijiazhuang Hongray Plastic Products Co., Ltd. | 1999-09-24 | 30 | 0 |
| K982720 | H-RAY | Shijiazhuang Hongray Plastic Products Co., Ltd. | 1998-11-05 | 93 | 0 |
| K964321 | GLOVE, PATIENT EXAMINATION, VINYL (POWDERED) | Shijiazhuang Hongray Plastic Products Co., Ltd. | 1997-01-09 | 72 | 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