The following data is part of a premarket notification filed by Grand Work Plastic Products Co., Ltd with the FDA for Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (blue).
Device ID | K220249 |
510k Number | K220249 |
Device Name: | Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue) |
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 |
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 | 2022-01-31 |
Decision Date | 2022-05-26 |