Description
At 400 mm (16 in.) BioClean Extra Sterile Latex Gloves provide elbow length protection and flexibility and comfort for prolonged use. This natural-colored glove features a textured surface and a beaded cuff for strength.
• Flexible & comfortable
• Elbow length protection
• Powder-free
• Beaded cuff
• Easy double-donning
• Non-particulating EasyTear packaging
Specifications:
• Compatibility: ISO Class 4 & EU GMP Grade A
• Length: 400 mm (16 in.)
• Cuff thickness: 4.72 mil.
• Palm thickness: 6.69 mil.
• Finger thickness: 8.27 mil.
• Material: Latex
• Protein Level: Less than 50 µg/gram
• Surface: Textured
• Color: Natural
• Shape: Ambidextrous
• Sterilization: Gamma irradiation
• Sterility Assurance Level: 10-6
• Freedom from Holes: 1.5 AQL
• Performance Level: 2
• Packaging: One pair per inner PE wallet; one wallet per sealed EasyTear PE pouch; 10 pouches per sealed outer PE bag; 20 outer bags per lined carton (200 pairs)
Quality Standards:
• Manufactured in a facility holding ISO 9001:2015 and (EU)2016/425 Module D certifications
• Conforms to Category 3 – Complex Design Personal Protective Equipment PPE Regulation (EU)2016/425
• Processed in an NEBB certified ISO Class 4 environment
• Complies with the requirements of European Glove Standards EN420:2003 +A1:2009 and EN374-1:2016, EN374-5:2016 and EN421:2010
• Physical properties comply with European Medical Glove Standard EN455-2:2015
• Sterilized in accordance with ISO 11137-1:2006
• Suitable for contact with all foodstuffs. Regulation (EC)1935/2004 and (EC) 2023/2006
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