Indications for Use Statement

Medical Face Mask is Intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of micro organisms, body fluids and particulate material.

About Medical Face Mask

510(k) Number:   K201601

Regulation Number:   878.4040

Classification Product Code: FXX

Date Received:  06/12/2020

Decision Date:   11/10/2020

Decision:   Substantially Equivalent (SESE)

Regulation Medical Specialty: General & Plastic Surgery

510k Review Panel:  General Hospital

About INT Medical

Shanghai Kindly Medical Instruments Co., Ltd. was established in 2006, a listed company on main board of Hong Kong Exchange (KDL Medical; HK1501).

We own over 1,000 employees. The headquarter is located in Jiading, Shanghai, manufacturing cardiovascular, peripheral and neuro intervention products approved by CE and FDA (510K), with a complete industrial chain of independent mold processing, product research and development, equipment development, sterilization, etc..