The following data is part of a premarket notification filed by Guangdong Kingfa Sci. & Tech. Co., Ltd. with the FDA for Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color.
Device ID | K221887 |
510k Number | K221887 |
Device Name: | Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color |
Classification | Polymer Patient Examination Glove |
Applicant | Guangdong Kingfa Sci. & Tech. Co., Ltd. No. 28 Delong Ave., Shijiao Town, Qingcheng District Qingyuan, CN 511545 |
Contact | Xiaoge Yu |
Correspondent | Xiaoge Yu Guangdong Kingfa Sci. & Tech. Co., Ltd. No. 28 Delong Ave., Shijiao Town, Qingcheng District Qingyuan, CN 511545 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-06-29 |
Decision Date | 2022-09-24 |