Shen Wei (Usa), Inc.: FDA filings under this applicant name
FDA lists 40 510(k) clearances under the applicant name “Shen Wei (Usa), Inc.” (first 1989, latest 2016), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 101 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 | 4 | 148 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 213 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 19 | 19 |
| LYY | Latex Patient Examination Glove | 13 | 13 |
| LYZ | Vinyl Patient Examination Glove | 5 | 5 |
| LZC | Medical Glove, Specialty | 2 | 2 |
| KGO | Surgeon'S Gloves | 1 | 1 |
Review panels
- General Hospital (40)
Most recent Shen Wei (Usa), Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161074 | Powder Free Nitrile Examination Gloves Flock-Lined, Black Color | LZA | 2016-11-17 | 213 |
| K121811 | POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES | LZC | 2012-11-21 | 154 |
| K121528 | POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR | LZA | 2012-09-11 | 111 |
| K120890 | POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE | LZA | 2012-08-17 | 147 |
| K113233 | POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM | KGO | 2012-03-29 | 148 |
| K101436 | PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) | LZC | 2010-11-17 | 177 |
| K100211 | PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA | LYY | 2010-05-11 | 106 |
| K092411 | PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) | LZA | 2009-10-21 | 75 |
| K090194 | POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR | LZA | 2009-07-07 | 161 |
| K061756 | TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP | LZA | 2007-04-19 | 302 |
30 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shen Wei (Usa), Inc..
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.
- Shen Wei USA, Inc. (18 510(k)s)
- Shen Zhen Cosbeauty Co., Ltd. (2 510(k)s)
- Shen Zhen Rong Feng Technology Co., Ltd. (2 510(k)s)
- Shen Yunn Plastics Corp. (1 510(k)s)
- Shen Zhen Cambridge-Hit Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shen Wei (Usa), Inc.?
FDA lists 40 510(k) clearances under the applicant name “Shen Wei (Usa), Inc.” (first 1989, latest 2016), across 5 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 Shen Wei (Usa), Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shen Wei (Usa), Inc. is 101 days.
Which FDA product codes appear under Shen Wei (Usa), Inc.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 19); LYY (Latex Patient Examination Glove, 13); LYZ (Vinyl Patient Examination Glove, 5).
Next steps
- See all 40 Shen Wei (Usa), Inc. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Shen Wei (Usa), Inc.'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.