The following data is part of a premarket notification filed by Shen Wei Usa Inc. with the FDA for Biodegradable Powder Free Nitrile Exam Gloves With Aloe Vera, Green Color.
| Device ID | K162312 |
| 510k Number | K162312 |
| Device Name: | Biodegradable Powder Free Nitrile Exam Gloves With Aloe Vera, Green Color |
| Classification | Polymer Patient Examination Glove |
| Applicant | SHEN WEI USA INC. 33278 CENTRAL AVE STE 102 Union City, CA 94587 |
| Contact | Cheryl Bailey-kroll |
| Correspondent | Cheryl Bailey-kroll SHEN WEI USA INC. 33278 CENTRAL AVE STE 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 | 2016-08-18 |
| Decision Date | 2017-07-25 |
| Summary: | summary |