The following data is part of a premarket notification filed by Grand Work Plastic Products Co., Ltd with the FDA for Vinyl Co-polymer Powder-free Examination Gloves, Black.
| Device ID | K220240 |
| 510k Number | K220240 |
| Device Name: | Vinyl Co-Polymer Powder-free Examination Gloves, Black |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Grand Work Plastic Products Co., Ltd Donggao Industrial Zone, Zanhuang Shijiazhuang, CN 050000 |
| Contact | Wu Yuli |
| Correspondent | Kathy Liu Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, CA 91710 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-28 |
| Decision Date | 2022-03-31 |