The following data is part of a premarket notification filed by Shen Wei Usa Inc. with the FDA for Powder Free Nitrile Exam Glove W/ph Coating, White-black Color, Tested For Use With Chemo Dr.
| Device ID | K170290 |
| 510k Number | K170290 |
| Device Name: | Powder Free Nitrile Exam Glove W/pH Coating, White-Black Color, Tested For Use With Chemo Dr |
| 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 | 2017-01-30 |
| Decision Date | 2017-05-24 |