The following data is part of a premarket notification filed by Shen Wei Usa Inc. with the FDA for 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.
| Device ID | K213142 |
| 510k Number | K213142 |
| Device Name: | 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 |
| Classification | Polymer Patient Examination Glove |
| Applicant | Shen Wei USA Inc. 33278 Central Ave Ste 102 Union City, CA 94587 |
| Contact | Cheryl Reep |
| Correspondent | Cheryl Reep Shen Wei USA Inc. 33278 Central Ave Ste 102 Union City, CA 94587 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-27 |
| Decision Date | 2022-01-28 |