Further Information:
• The soft, stretchy polyisoprene formulation means these surgical gloves are more comfortable than standard latex alternatives, making them ideal for double–gloving.
• The external glove surface of these latex–free, powder–free gloves features a micro–textured finish for excellent grip, allowing the glove to also be used in single–glove conditions.
• With Donning Aid Technology for easy dry or damp hand donning and also to help to minimize the feel of sweaty hands.
• Latex and powder free, protecting against chemical Type IV allergies and sensitivities for an optimized allergenic profile.
Specification:
Material: PI (Polyisoprene)
Powder Content: Powder Free
Shape: Anatomic with Curved Fingers
Thickness: Micro
Cuff Style: Beaded with SUREFIT™ Technology
External Glove Surface: Smooth with Micro-Textured Finish
Internal Glove Surface: Polymer Coated with DERMASHIELD™ Technology
Allergy Prevention: Latex (Type I)
Grip Level: Low
Double Gloving Recommendation: Underglove
Primary Skin Irritation: Not considered a primary irritant as per FHSA Regulation guidelines 16 CFR 1500 / ISO 10993-10
Skin Sensitization: No evidence of delayed dermal contact sensitization as per ISO 10993-10
Protein Level: N/A: contains no natural rubber latex
Tested For Use With Chemotherapy Drugs: Yes, in accordance with ASTM D6978 (Not listed in the US FDA 510k)
Viral Penetration: Passes ASTM F1671 using Phi X 174, Passes ISO 16604 using Phi X 174
Freedom from Holes (Inspection level I): 0.65 AQL
Product Standards: AS/NZS 4179, ASTM D3577, ASTM D6978, ASTM D7160, EN 16523-1, EN 455 1-4, EN ISO 21420:2020, EN ISO 374-1:2016, EN ISO 374-5:2016, ISO 10282
Quality / Environmental Standards: EN 556, ISO 11137-Part 1, ISO 13485, ISO 14001, ISO 9001
Product Certification: EU: CE Marked to MDD 93/42/EEC (Class IIa), PPE Regulation (EU) 2016/425 (Cat. III risks) US: 510K # K071746, Class I / CA: MDALL # 72514, Class 2 AU: TGA # 277379
Storage Instructions: Keep out of direct sunlight; store in a cool and dry place. Keep away from sources of ozone or ignition.
Vulcanization Chemical Accelerators: Xanthates, Zinc Dialkyldithiocarbamate