Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shijiazhuang Hongxiang Plastics Products Co., Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
22 daysmedian FDA review time
203 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053521 | PRE-POWDERED STERILE VINYL GLOVE, CLEAR | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | 2006-03-29 | 100 | 0 |
| K053523 | POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW) | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | 2006-02-14 | 57 | 0 |
| K042247 | SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER F | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | 2004-09-02 | 14 | 0 |
| K001861 | SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Hongxiang Plastics Products Co; , Ltd. | 2000-07-11 | 22 | 0 |
| K001863 | SYNTHETIC POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Hongxiang Plastics Products Co; , Ltd. | 2000-07-11 | 22 | 0 |
| K001834 | SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLO | Shijiazhuang Hongxiang Plastics Products Co; , Ltd. | 2000-06-30 | 14 | 0 |
| K001862 | SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOV | Shijiazhuang Hongxiang Plastics Products Co; , Ltd. | 2000-06-30 | 11 | 0 |
| K992821 | SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | 2000-03-10 | 203 | 1 |
| K992797 | SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | 1999-11-05 | 78 | 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