The following data is part of a premarket notification filed by Shen Wei Usa Inc. with the FDA for Powder Free Nitrile Examination Gloves With Aloe Vera, Orange And Orange-white Colors.
| Device ID | K211455 |
| 510k Number | K211455 |
| Device Name: | Powder Free Nitrile Examination Gloves With Aloe Vera, Orange And Orange-White Colors |
| 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 |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-10 |
| Decision Date | 2021-07-28 |