FDA 510(k) Applications Submitted by SHEN WEI USA INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K162312 |
08/18/2016 |
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color |
SHEN WEI USA INC. |
| K170290 |
01/30/2017 |
Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr |
Shen Wei USA Inc. |
| K190466 |
02/26/2019 |
PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate |
Shen Wei USA Inc. |
| K211455 |
05/10/2021 |
Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors |
Shen Wei USA Inc. |
| K211620 |
05/26/2021 |
Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less) |
Shen Wei USA Inc. |
| K202076 |
07/27/2020 |
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors |
Shen Wei USA Inc. |
| K202078 |
07/27/2020 |
Biodegradable Thermoplastic Elastomer Examination (TPE) Glove |
Shen Wei USA Inc. |
| K202080 |
07/27/2020 |
Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color |
Shen Wei USA Inc. |
| K202081 |
07/27/2020 |
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue |
Shen Wei USA Inc. |
| K202082 |
07/27/2020 |
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 |
Shen Wei USA Inc. |
| K202083 |
07/27/2020 |
Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs |
Shen Wei USA Inc. |
| K202085 |
07/27/2020 |
Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green |
Shen Wei USA Inc. |
| K202086 |
07/27/2020 |
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 |
Shen Wei USA Inc. |
| K172678 |
09/05/2017 |
THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE |
Shen Wei USA Inc. |
| K213141 |
09/27/2021 |
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 |
Shen Wei USA Inc. |
| K213142 |
09/27/2021 |
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 |
Shen Wei USA Inc. |
| K213144 |
09/27/2021 |
Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors |
Shen Wei USA Inc. |
| K173766 |
12/11/2017 |
PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs |
Shen Wei USA Inc. |
|
|
