The following data is part of a premarket notification filed by Grand Work Plastic Products Co., Ltd with the FDA for Sterile Powder Free Nitrile Examination Gloves (blue), Tested For Use With Chemotherapy Drugs.
| Device ID | K220250 |
| 510k Number | K220250 |
| Device Name: | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs |
| Classification | Polymer 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-31 |
| Decision Date | 2022-05-11 |