Shen Wei USA, Inc.
FDA 510(k) & PMA Approved Devices — 18 products
Total Devices18
Categories4
Latest Approval2022-05-28
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | 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 | View |
| 510(k) | 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 | View |
| 510(k) | K213144 | Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors | LYZ | 2021-12-22 | View |
| 510(k) | 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 | View |
| 510(k) | K211455 | Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors | LZA | 2021-07-28 | View |
| 510(k) | K202085 | Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green | LZA | 2021-06-21 | View |
| 510(k) | 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 | View |
| 510(k) | K202080 | Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color | LZA | 2021-03-24 | View |
| 510(k) | K202081 | Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue | LZA | 2021-03-19 | View |
| 510(k) | 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 | View |
| 510(k) | K202086 | Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors | LZA | 2021-03-16 | View |
| 510(k) | K202076 | Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors | LZA | 2021-03-05 | View |
| 510(k) | K202078 | Biodegradable Thermoplastic Elastomer Examination (TPE) Glove | LZA | 2021-03-05 | View |
| 510(k) | K190466 | PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate | LZA | 2019-09-26 | View |
| 510(k) | K173766 | PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs | LZC | 2018-07-08 | View |
| 510(k) | K172678 | THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE | LZA | 2017-11-24 | View |
| 510(k) | K162312 | Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color | LZA | 2017-07-25 | View |
| 510(k) | K170290 | Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr | LZA | 2017-05-24 | View |
No matching devices.