Examination Nitrile Gloves

Medical Examination Nitrile Gloves

KG-1101

Our gloves are manufactured by overcoming numerous tests based on the corresponding regulations. Company has a daily production capacity of 1,000,000 units per line. At the end of 2021, We will have 96 functional production lines, reaching a total daily production capacity of over 100,000,000 units.

INTENDED USE

Our medical examination nitrile gloves are intended to be worn on the hands of healthcare personnel to prevent contamination between patients and examiners. This is a single-use, powder-free, non-sterile device.

FEATURE

                          · Excellent mechanical strength provides a high level of hand protection.

                          · Protection against bacteria and fungi.

                          · Textured in finger tips for a secure grip.

                          · Skin irritation & sensitization tested.

STANDARDS AND CERTIFICATIONS

FDA Premarket Notifications 510(k):

ASTM D6319

MANUFACTURING ACCREDITATIONS

                                       · ISO/IEC 17025 State Accredited Laboratory

                                       · ISO9001 Quality Management System Certification

                                       · ISO13485 Medical Device Quality Management System

                                       · QSR820 FDA Quality System Requirements

                                       · ISO14001 Environment Management System

REGULATORY COMPLIANCE

                                                      21 U.S.C. ch.9                   EU 2016/425

                                                      MDD 93/42/EEC                EC 10/011

                                                      REACH                              EC1935/2004