The following data is part of a premarket notification filed by Guangdong Gymda Medical Technology Co., Ltd with the FDA for Medical Examination Gloves.
|Device Name:||Medical Examination Gloves|
|Classification||Polymer Patient Examination Glove|
|Applicant||Guangdong Gymda Medical Technology Co., Ltd No.13, Quan'an Third Road, Phase 2 Of High-tech Zone Nanxiong, CN 512400|
Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, CN 200120
|CFR Regulation Number||880.6250 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|