The following data is part of a premarket notification filed by Fujian Yuanxin Safety Protection Technology Co., Ltd. with the FDA for Disposable Nitrile Examination Gloves.
Device ID | K212485 |
510k Number | K212485 |
Device Name: | Disposable Nitrile Examination Gloves |
Classification | Polymer Patient Examination Glove |
Applicant | Fujian Yuanxin Safety Protection Technology Co., Ltd. Xiacun Medical Industry Zone, Zherong County Ningde, CN 355300 |
Contact | Alan Wu |
Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room608,No.738,Shangcheng Rd.,Pudong Shanghai, CN 200120 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-08-09 |
Decision Date | 2021-11-05 |