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 & White-black Colors, Tested For Use With Chemotheraphy Drugs And Fentanyl Citrate.
| Device ID | K190466 |
| 510k Number | K190466 |
| Device Name: | PF Nitrile Exam Glove With PH Coating, Black-Gray & White-Black Colors, Tested For Use With Chemotheraphy Drugs And Fentanyl Citrate |
| 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 |
| Subsequent Product Code | LZC |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-26 |
| Decision Date | 2019-09-26 |