Further Information:

• Pre–donned double–gloving system with aligned polyisoprene gloves reduces donning time by enabling wearers to double glove in one don.
• 50% less inner packaging minimizes the environmental footprint, providing a sustainable and eco–friendly solution.
• Non–latex gloves with PI–KARE Technology eliminate chemical accelerators, preventing allergic contact dermatitis and latex allergies.
• A.R.T Technology ensures robustness by minimizing defects, while DERMASHIELD Technology facilitates easy donning and doffing for both damp and dry hands during intraoperative changes.

Specification:

Material: PI (Polyisoprene)
Powder Content: Powder Free
Shape: Anatomic with Curved Fingers
Internal Glove Surface: Polymer Coated with DERMASHIELD™ Technology
External Glove Surface: Textured Fingers and Palm
Cuff Style: Beaded with SUREFIT™ Technology
Glove Length Typical (mm/in): Outer: 305 / 12.0; Inner: 303 / 11.9
Vulcanization Chemical Accelerators: Xanthates, Zinc Dialkyldithiocarbamate
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
Allergy Prevention: Latex (Type I)
Freedom From Holes (AQL): 0.65 AQL
Sterilization Method: GAMMA irradiation (25 kGy)
Tested For Use With Chemotherapy Drugs: Yes, in accordance with ASTM D6978 and US FDA cleared
Viral Penetration: Passes ASTM F1671 using Phi X 174, Passes ISO 16604 using Phi X 174
Product Standards: AS/NZS 4179, ASTM D3577, ASTM D7160, ASTM F739, EN 16523-1, EN 455 1-4, EN ISO 21420:2020, EN ISO 374-1:2016, EN ISO 374-5:2016, ISO 10282, JIS T9107
Quality / Environmental Standards: EN 556, ISO 11137-Part 1, ISO 13485, ISO 14001, ISO 9001
Product Certification: EU: CE Marked to Medical Device Regulation (EU) 2017/745 (Class IIa), PPE Regulation (EU) 2016/425 (Cat. III risks); US: 510K # K071746, Class I / CA: MDALL # 72514, Class 2; AU: TGA # 298982
Shared Storage Instructions: Keep out of direct sunlight; store in a cool and dry place. Keep away from sources of ozone or ignition.
Disposal Recommendations: Gloves and pouch should be disposed of as clinical waste. Paper inner wrap, box, and carton/case are recyclable but can be disposed of as clinical waste.