DEVICE DETAILS
| NAME OF DEVICE | KN100/FFP3 SURGICAL FACE MASK |
|---|---|
| ESTABLISHMENT NAME | GSH PRECISION TECHNOLOGY SDN BHD |
| ROLE OF ESTABLISHMENT | MANUFACTURER |
| REGISTRATION NO | GA1140421-78574 |
| BRAND NAME | GSH |
| MEDICAL DEVICE CATEGORY | SINGLE-USE DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | 5-ply medical grade respirator that offer filtration-efficient, fluid-resistant, superior comfort and breathability to help reduce wearer to exposure of potential bacteria, infection particles, blood and body fluids |
| DEVICE INTENDED PURPOSE | GSH-KN100 Surgical Mask is intended to be worn by health professionals during surgery and certain health care procedures to catch microorganisms shed in liquid droplets and aerosols from the wearer's mouth and nose. The medical personnel are dressed with them in operation so that the blood, body fluid and exudation of patientsm which has poetntial infection, can be obstructed effectively to prevent the bacteria infection. All parts of the products and processing materials are used to meet the requirements of medical material, cenvenient use, safety, etc. |
| VALIDITY DATE OF REGISTRATION | 21/11/2021 - 20/11/2026 |