Xuzhou Full Sun Medical Products , Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Xuzhou Full Sun Medical Products , Ltd.” (first 2007, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 105 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 341 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Xuzhou Full Sun Medical Products , Ltd. took a median 341 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | 7 | 7 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Xuzhou Full Sun Medical Products , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210463 | Thermoplastic Elastomer (TPE) Hybrid Examination Glove | LZA | 2022-01-23 | 341 |
| K111240 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR | LYZ | 2011-07-14 | 72 |
| K072377 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COLOR | LYZ | 2007-12-14 | 112 |
| K072314 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR | LYZ | 2007-12-12 | 117 |
| K071122 | DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR | LYZ | 2007-12-12 | 233 |
| K072472 | DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED | LYZ | 2007-10-25 | 51 |
| K072401 | DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR | LYZ | 2007-10-15 | 49 |
| K071123 | DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR | LYZ | 2007-07-30 | 98 |
Recalls
openFDA lists no recalls under a recalling firm named Xuzhou Full Sun Medical Products , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Xuzhou Kernel Medical Equipment Co., Ltd. (9 510(k)s)
- Xuzhou Yongkang Electronic Science Technology Co., Ltd. (6 510(k)s)
- Xuzhou Kaixin Electronic Instrument Co., Ltd. (1 510(k)s)
- Xuzhou Maicuff Technology Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Xuzhou Full Sun Medical Products , Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Xuzhou Full Sun Medical Products , Ltd.” (first 2007, latest 2022), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Xuzhou Full Sun Medical Products , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Xuzhou Full Sun Medical Products , Ltd. is 105 days.
Which FDA product codes appear under Xuzhou Full Sun Medical Products , Ltd.?
The most frequent FDA product codes under this applicant name are LYZ (Vinyl Patient Examination Glove, 7); LZA (Polymer Patient Examination Glove, 1).
Next steps
- See all 8 Xuzhou Full Sun Medical Products , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LYZ, Xuzhou Full Sun Medical Products , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.