Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Xuzhou Full Sun Medical Products , Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
341 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210463 | Thermoplastic Elastomer (TPE) Hybrid Examination Glove | Xuzhou Full Sun Medical Products , Ltd. | 2022-01-23 | 341 | 0 |
| K111240 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BL | Xuzhou Full Sun Medical Products , Ltd. | 2011-07-14 | 72 | 0 |
| K072377 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COL | Xuzhou Full Sun Medical Products , Ltd. | 2007-12-14 | 112 | 0 |
| K071122 | DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR | Xuzhou Full Sun Medical Products , Ltd. | 2007-12-12 | 233 | 0 |
| K072314 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALO | Xuzhou Full Sun Medical Products , Ltd. | 2007-12-12 | 117 | 0 |
| K072472 | DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED | Xuzhou Full Sun Medical Products , Ltd. | 2007-10-25 | 51 | 0 |
| K072401 | DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR | Xuzhou Full Sun Medical Products , Ltd. | 2007-10-15 | 49 | 0 |
| K071123 | DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR | Xuzhou Full Sun Medical Products , Ltd. | 2007-07-30 | 98 | 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