The following data is part of a premarket notification filed by Shen Wei Usa Inc. with the FDA for Pf Nitrile Exam Glove With Ph Coating, Black-gray Color, Tested For Use With Chemo Drugs.
| Device ID | K173766 |
| 510k Number | K173766 |
| Device Name: | PF Nitrile Exam Glove With PH Coating, Black-Gray Color, Tested For Use With Chemo Drugs |
| Classification | Patient Examination Glove, Specialty |
| 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 | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-11 |
| Decision Date | 2018-07-08 |