The following data is part of a premarket notification filed by Shen Wei Usa Inc. with the FDA for 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.
| Device ID | K213141 |
| 510k Number | K213141 |
| Device Name: | 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 |
| Classification | Polymer Patient Examination Glove |
| Applicant | Shen Wei USA Inc. 33278 Central Ave. Suite 102 Union City, CA 94587 |
| Contact | Cheryl Reep |
| Correspondent | Cheryl Reep Shen Wei USA Inc. 33278 Central Ave. Suite 102 Union City, CA 94587 |
| Product Code | LZA |
| 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 | 2022-05-28 |