Saf-Care PLUS PURE Latex series made with renewable resources encourage users to experience hand protection that promotes sustainability. They are specially designed to provide outstanding Protection Against Cross-Contamination of  Microbes Viruses, Pathogens & General Harmful Substances, while offering exceptional tactile Sensitivity, dexterity, durability and resistance to tears and punctures.

Saf-Care PLUS PURE天然系列使用可再生資源天然乳膠製成,鼓勵用戶體驗可促進可持續性的天然手套。 它們經過專門設計,可提供出色的防護,以防止病毒,細菌病原體和一般有害物質的交叉污染,同時提供出色的觸感,靈巧性,耐用性和抗撕裂性和抗穿刺性(乳膠過敏者不適用) 

Latex Examination Gloves, Powder free, AQL1.5, Premium Quality, Standard Cuff Length Min.240mm   

高品質 高防護 天然乳膠手套 - 高規格醫療級 食品處理安全級 AQL1.5

使用可再生資源天然乳膠製成,鼓勵用戶體驗可促進可持續性的天然手套。 它們經過專門設計,可提供出色的防護,以防止病毒,細菌病原體和一般有害物質的交叉污染,同時提供出色的觸感,靈巧性,耐用性和抗撕裂性和抗穿刺性(乳膠過敏者不適用)

無粉標準長度 Min.240mm 有特殊塗層提高乾手的穿戴能力。恰當的厚度分佈,提高觸感。舒適柔軟,全麻面加強了抓握力和防滑性,可有效處理儀器。 在乾燥和潮濕條件下都可牢握儀器。

Product Code: SF2200

Powder-free standard cuff Length Min.240mm natural latex gloves, with special polymer coated to provide good dry hand donning capability.

Full textured surface enhances grip for efficient instrument handling. Strong grip for medical instrument or object handling in dry and wet conditions. Good thickness distribution for tactile sensitivity.

US FDA 510(k) compliant, Medical MDR (EU) 2017/745 compliant, PPE (EU) 2016/425, CAT III compliant, FDA & EU Food Grade compliant.

Suitable for all types of Medical & Dental examination, home health care and diagnostic, laboratory, food handling and various industry use.

Tested against                                           

* MDR (EU) 2017/745 EN455 1, 2, 3 & 4

* PPE Regulation (EU) 2016/425 CAT III, EN ISO 374-5  for protection against bacteria, fungi and VIRUS, EN ISO 374-1 against chemicals

* Food Safe handling EU10/2011 (EN1186) & US FDA 21 CFR 177.2600                                                          

* Primary Skin Irritation and Dermal Sensitization Assay (ISO 10993-10)  

* Cytotoxicity (ISO 10093-5)                                 

* Chemotherapy Drugs Permeation (ASTM D6978), selected chemicals only                                     

* Resistance to Chemical Permeation (EN16523-1), selected chemicals only

* Viral Penetration ASTM F1671

Provides outstanding barrier protection against blood-borne pathogen, viruses, bacteria, selected chemicals and chemotherapy drugs.

* It is important to review the chemical/chemodrugs test report(s) to determine the required level of protection as result may vary for different gloves

   請務必參考化學藥品測試報告以確定所需的防護等級,因為每種手套的測試結果可能有所不同

Latex Examination Gloves(+Thickness), Powder free, AQL1.5, Premium Quality, Standard Cuff Length Min.240mm 

(特厚款*)高品質 高防護 天然乳膠手套 - 高規格醫療級 食品處理安全級 AQL1.5

使用可再生資源天然乳膠製成,鼓勵用戶體驗可促進可持續性的天然手套。 它們經過專門設計,可提供出色的防護,以防止病毒,細菌病原體和一般有害物質的交叉污染,同時提供出色的觸感,靈巧性,耐用性和抗撕裂性和抗穿刺性(乳膠過敏者不適用)

無粉標準長度 Min.240mm 有特殊塗層提高乾手的穿戴能力。恰當的厚度分佈,提高觸感。舒適柔軟,全麻面加強了抓握力和防滑性,可有效處理儀器。 在乾燥和潮濕條件下都可牢握儀器。

Product Code: SF2300

Powder-free standard cuff Length Min.240mm natural latex gloves, with special polymer coated to provide good dry hand donning capability.

Full textured surface enhances grip for efficient instrument handling. Strong grip for medical instrument or object handling in dry and wet conditions. Good thickness distribution for tactile sensitivity.

US FDA 510(k) compliant, Medical MDR (EU) 2017/745 compliant, PPE (EU) 2016/425, CAT III compliant, FDA & EU Food Grade compliant.

Suitable for all types of Medical & Dental examination, home health care and diagnostic, laboratory, food handling and various industry use.

Tested against                                           

* MDR (EU) 2017/745 EN455 1, 2, 3 & 4

* PPE Regulation (EU) 2016/425 CAT III, EN ISO 374-5  for protection against bacteria, fungi and VIRUS, EN ISO 374-1 against chemicals

* Food Safe handling EU10/2011 (EN1186) & US FDA 21 CFR 177.2600                                                          

* Primary Skin Irritation and Dermal Sensitization Assay (ISO 10993-10)  

* Cytotoxicity (ISO 10093-5)                                 

* Chemotherapy Drugs Permeation (ASTM D6978), selected chemicals only                                     

* Resistance to Chemical Permeation (EN16523-1), selected chemicals only

* Viral Penetration ASTM F1671

Provides outstanding barrier protection against blood-borne pathogen, viruses, bacteria, selected chemicals and chemotherapy drugs.

* It is important to review the chemical/chemodrugs test report(s) to determine the required level of protection as result may vary for different gloves

   請務必參考化學藥品測試報告以確定所需的防護等級,因為每種手套的測試結果可能有所不同

Latex Examination Gloves, Powder free, AQL1.5, High Protection, Extra Thickness, Long Cuff, UL NFPA Certified 

(特厚加長款*)高品質 高防護 天然乳膠手套 - 高規格醫療級 食品處理安全級 AQL1.5, EMS 急救 UL級 NFPA 認證

使用可再生資源天然乳膠製成,鼓勵用戶體驗可促進可持續性的天然手套。 它們經過專門設計,可提供出色的防護,以防止病毒,細菌病原體和一般有害物質的交叉污染,同時提供出色的觸感,靈巧性,耐用性和抗撕裂性和抗穿刺性。(乳膠過敏者不適用)

這款無粉天然橡膠乳膠檢查手套經過專門設計,袖口加長 Min. 295mm 並增加了特厚度,適用於高風險醫療應用,專為針對血液傳播病原體和病毒醫療操作的用戶提供了高度保護。該手套符合NFPA 1999 國家消防協會關於緊急醫療操作的防護服的標準 緊急醫療檢查手套的標準要求 ,緊急醫療操作的UL分類,一次性使用的防護檢查手套要求 。

Product Code: SF2500

NFPA

  UL

This Powder-free Natural Rubber Latex Examination Gloves are designed with extra thickness and with extended cuff length in order to provide greatest protection which is essential in vigorous handling during medical emergency situations. It provides outstanding barrier protection against blood-borne pathogen, viruses, bacteria, selected chemicals and chemotherapy drugs.

NFPA 1999-2013

This glove meets the single-use emergency medical examination glove requirements of NFPA 1999, standard on protective clothing and ensembles for emergency medical operations, 2013 edition.       

UL Classified, Protective single-use examination gloves for emergency medical operations in accordance with the national fire protection association standard on protective clothing and ensembles for emergency medical operations, NFPA 1999-2013.­ 

US FDA 510(k) compliant, Medical MDR (EU) 2017/745 compliant, PPE (EU) 2016/425, CAT III compliant, FDA & EU Food Grade compliant.

Suitable for all types of Medical & Dental examination, home health care and diagnostic, laboratory, food handling and various industry use.

Tested against                                           

* MDR (EU) 2017/745 EN455 1, 2, 3 & 4

* PPE Regulation (EU) 2016/425 CAT III, EN ISO 374-5  for protection against bacteria, fungi and VIRUS, EN ISO 374-1 against chemicals

* Food Safe handling EU10/2011 (EN1186) & US FDA 21 CFR 177.2600                                                          

* Primary Skin Irritation and Dermal Sensitization Assay (ISO 10993-10)  

* Cytotoxicity (ISO 10093-5)                                 

* Chemotherapy Drugs Permeation (ASTM D6978), selected chemicals only                                     

* Resistance to Chemical Permeation (EN16523-1), selected chemicals only

* Viral Penetration ASTM F1671

* NFPA 1999 (2018) 

Provides outstanding barrier protection against blood-borne pathogen, viruses, bacteria, selected chemicals and chemotherapy drugs.

* It is important to review the chemical/chemodrugs test report(s) to determine the required level of protection as result may vary for different gloves

   請務必參考化學藥品測試報告以確定所需的防護等級,因為每種手套的測試結果可能有所不同

Latex Examination Gloves, Powder free, AQL1.5, High Risk Emergency, Length Min. 295mm UL NFPA Certified

(特厚加長款*)高品質 高防護 藍色 天然乳膠手套 - 高規格醫療級 食品處理安全級 AQL1.5, EMS 急救 UL級 NFPA 認證

使用可再生資源天然乳膠製成,鼓勵用戶體驗可促進可持續性的天然手套。 它們經過專門設計,可提供出色的防護,以防止病毒,細菌病原體和一般有害物質的交叉污染,同時提供出色的觸感,靈巧性,耐用性和抗撕裂性和抗穿刺性。(乳膠過敏者不適用)

這款無粉天然橡膠乳膠檢查手套經過專門設計,袖口加長 Min. 295mm 並增加了特厚度,適用於高風險應用,還專為針對血液傳播的病原體和病毒提供了高度保護。該手套符合NFPA 1999 國家消防協會關於緊急醫療操作的防護服的標準 緊急醫療檢查手套的標準要求 ,緊急醫療操作的UL分類,一次性使用的防護檢查手套要求 。

NFPA

  UL

Product Code: PS9000

This Powder-free Natural Rubber Latex Examination Gloves are designed with extra thickness and with extended cuff length Min. 295mm in order to provide greatest protection which is essential in vigorous handling during high risk and emergency situations.

NFPA 1999-2013

This glove meets the single-use emergency medical examination glove requirements of NFPA 1999, standard on protective clothing and ensembles for emergency medical operations, 2013 edition.       

UL Classified, Protective single-use examination gloves for emergency medical operations in accordance with the national fire protection association standard on protective clothing and ensembles for emergency medical operations, NFPA 1999-2013.­

US FDA 510(k) compliant, Medical MDR (EU) 2017/745 compliant, PPE (EU) 2016/425, CAT III compliant, FDA & EU Food Grade compliant.

Suitable for all types of Medical & Dental examination, home health care and diagnostic, laboratory, food handling and various industry use.

Tested against                                           

* MDR (EU) 2017/745 EN455 1, 2, 3 & 4

* PPE Regulation (EU) 2016/425 CAT III, EN ISO 374-5  for protection against bacteria, fungi and VIRUS, EN ISO 374-1 against chemicals

* Food Safe handling EU10/2011 (EN1186) & US FDA 21 CFR 177.2600                                                          

* Primary Skin Irritation and Dermal Sensitization Assay (ISO 10993-10)  

* Cytotoxicity (ISO 10093-5)                                 

* Chemotherapy Drugs Permeation (ASTM D6978), selected chemicals only                                     

* Resistance to Chemical Permeation (EN16523-1), selected chemicals only

* Viral Penetration ASTM F1671

* NFPA 1999 (2018)

Provides outstanding barrier protection against blood-borne pathogen, viruses, bacteria, selected chemicals and chemotherapy drugs.

* It is important to review the chemical/chemodrugs test report(s) to determine the required level of protection as result may vary for different gloves

   請務必參考化學藥品測試報告以確定所需的防護等級,因為每種手套的測試結果可能有所不同

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

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