Further Information:

• Encore^® Non–Latex PI Surgical Undergloves are ultra–thin, ensuring superior sensitivity and comfort when double gloving during surgeries.
• Their green colour allows for quick and efficient identification of glove breaches, enhancing safety in high–risk procedures.
• The PI glove offers a softer and more stretchable alternative to latex gloves, ensuring exceptional comfort for medical professionals.
• Free from chemical accelerators known to cause Type IV allergies, it provides a skin–friendly solution for healthcare workers and patients alike.
• Suitable as both an underglove for double gloving and as a single glove, it offers flexibility and performance for various medical procedures, including IVF.

Specification:

Material: Polyisoprene (PI)
Powder Content: Powder Free
Shape: Anatomic with Curved Fingers
Internal Glove Surface: Polymer Coated with DERMASHIELD™ Technology
External Glove Surface: Smooth with Micro-Textured Finish
Cuff Style: Beaded with SUREFIT™ Technology
Glove Length (Typical): 303 mm / 11.9 inches
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
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 (Not listed in the US FDA 510k)
Viral Penetration: Passes ASTM F1671 using Phi X 174, Passes ISO 16604 using Phi X 174
Product Standards: ASTM D6978, EN 16523-1, EN 374-2 and -4, EN 455 1-4, EN ISO 21420:2020, EN ISO 374-1:2016, EN ISO 374-5:2016
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)
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.