STERILE MEDICAL GLOVES SERIES, POWDER-FREE

Sterile Latex Surgical Gloves Powder Free, Damp Donning, Double Gloving­

Sterile Latex Surgical Gloves Micro for Microsurgeries use, Powder Free, Damp Donning, Brown­

Sterile Latex Surgical Gloves, Spot Blue, Powder Free, Damp Donning

Sterile Nitrile Examination Gloves, Low Endotoxin, Biocompatible, Tested for Chemotheraphy drugs use

Sterile Nitrile Surgical Gloves, Powder Free, Damp Donning

Sterile Latex RPG Radiation Protection Gloves, Damp Donning, Lead Free, PPE Certification

Sterile Latex Surgical Gloves, Powder Free, Elbow Length 480mm

Saf-Care PLUS products meet the quality and performance of / Standard Compliance :

Food & Drug Administration, US FDA 510(k) Pre-market Notification  

Medical Grade: EU Medical Devices Regulation, MDR (EU) 2017/745, EN 455 1, 2, 3, 4 test standards 

PPE Grade:         EU Personal Protective Equipment Regulation, PPE (EU) 2016/425 Category III, EN 420, EN 374  test standards          

Food Grade:       EU 10/2011 (EN 1186), US FDA 21CFR177.2600

and other International  EN, ASTM test standards

Product manufactured under QSR (GMP), ISO 9001, ISO 13485 & EN ISO 13485 (Medical Device) Quality Management System  

Saf-Care PLUS 產品系列標準合規規格 :

美國食品藥品管理:  美國 US FDA 510(k) Pre-Market Notification 上市前通知規格認證 

醫療規格:                歐盟醫療器材法規 MDR (EU) 2017/745 認證, EN 455 1, 2, 3, 4 測試  

個人防護設備規格:  歐盟個人防護設備第三類別認證 PPE (EU) 2016/425 CAT III, EN 420, EN 374 測試             

食品安全規格:         歐盟食品接觸材料測試 EU 10/2011 (EN 1186), 美國食品接觸材料測試 US FDA 21CFR 177.2600 

及其他國際測試標準 EN, ASTM 質量測試

產品根據 QSR(GMP) , ISO 9001, ISO 13485 和 EN ISO 13485 (醫療器械) 質量管理體系生產