Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hong DI Plastic Products Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
71 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102099 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES | Hong DI Plastic Products Co., Ltd. | 2010-10-06 | 71 | 0 |
| K102098 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES | Hong DI Plastic Products Co., Ltd. | 2010-09-27 | 62 | 0 |
| K101132 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (BLUE, WHITE, | Hong DI Plastic Products Co., Ltd. | 2010-07-01 | 70 | 0 |
| K070188 | POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW | Hong DI Plastic Products Co., Ltd. | 2007-03-19 | 56 | 0 |
| K070187 | POWDER FREE VINYL PATIENT EXAMINATION GLOVE | Hong DI Plastic Products Co., Ltd. | 2007-02-13 | 22 | 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