Shen Wei USA, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Shen Wei USA, Inc.” (first 2017, latest 2022), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 221 days. Since 2017 the median was 221 days, against 110 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2017 | 3 | 114 |
| 2018 | 1 | 209 |
| 2019 | 1 | 212 |
| 2020 | 0 | — |
| 2021 | 11 | 232 |
| 2022 | 2 | 183 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shen Wei USA, Inc. took a median 221 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 15 | 15 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
| LYZ | Vinyl Patient Examination Glove | 1 | 1 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (18)
Most recent Shen Wei USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213141 | Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | LZA | 2022-05-28 | 243 |
| K213142 | Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution | LZA | 2022-01-28 | 123 |
| K213144 | Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors | LYZ | 2021-12-22 | 86 |
| K211620 | Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less) | LYY | 2021-08-19 | 85 |
| K211455 | Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors | LZA | 2021-07-28 | 79 |
| K202085 | Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green | LZA | 2021-06-21 | 329 |
| K202083 | Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs | LZA | 2021-03-25 | 241 |
| K202080 | Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color | LZA | 2021-03-24 | 240 |
| K202081 | Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue | LZA | 2021-03-19 | 235 |
| K202082 | Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid | LZA | 2021-03-17 | 233 |
8 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. (40 510(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 18 510(k) clearances under the applicant name “Shen Wei USA, Inc.” (first 2017, latest 2022), across 4 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 221 days. Since 2017: 221 days, versus 110 days for all cleared 510(k)s in the same product codes.
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, 15); LYY (Latex Patient Examination Glove, 1); LYZ (Vinyl Patient Examination Glove, 1).
Next steps
- See all 18 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.