Medical Nitrile Examination Glove

Product Details

Nitrile Examination Gloves – 245 mm/powder free online chlorination / finger textured cobalt blue color weight – 3.6gm (medium)

§ Tested for use with Chemotherapy Drugs

§ Medical Grade Examination Glove

§ A 510(K) premarket approved to FDA device (section 513(i)(1)(A) FD&C Act)

§ Tested for use with Chemotherapy Drugs using ASTM D6978

§ Latex free

§ Powder free

§ Disposable

§ Non – Sterile

§ Ambidextrous

Class: Class A

Standard: Tested for use with Chemotherapy Drugs using ASTM D6978 (Average breakthrough Detection Time (Specimen 1/2/3) (Minutes).

Certificate:

• FDA, Premarket approved
• ISO 9001
• EN ISO 13485
• FDA 510K
• AQL 1.5
• EN ISO 374 – 5: 2016
• EN ISO 374 – 1: 2016/Type C (Protective gloves against dangerous chemicals and micro-organisms)
• EU Medical Devices Regulation 2017/745 (Class 1)
• PPE Regulation (EU) 2016/425 (Category III)
• Conformance with European regulations. (CE 0598)

EN455 1-4:

• Part 1: Requirements and testing for freedom from holes
• Part 2: Requirements and testing for physical properties
• Part 3: Requirements and testing for biological evaluation
• Part 4: Requirements and testing for shelf-life determination