Further Information:

Introducing the GAMMEX^® PI Radiation Attenuation Gloves, designed to protect hands from scattered radiation during fluoroscopic procedures. With a high attenuation of 69.1%*, optimal thickness for dexterity and protection, and a lead–free, skin–friendly formulation, these gloves ensure safety without compromising performance. Recommended for image–guided interventional procedures such as fluoroscopy and interventional care.

• Experience unrivalled dexterity and tactile sensitivity with a proprietary polyisoprene formulation. These disposable gloves offer the perfect balance between dexterity and comfort, ensuring precise control during fluoroscopy and other image–guided procedures.
• Say goodbye to latex allergies and allergic contact dermatitis. The sterilised, latex–free gloves eliminate the risk of type I latex allergies. Plus, they contain no chemical accelerators known to cause allergic contact dermatitis.
• The special medical gloves in an elegant dark grey colour have a micro–textured surface. This not only improves aesthetics, but also ensures excellent grip. Give yourself safety and stability during delicate procedures.
• The radiation protection gloves are specially developed for use in the healthcare sector and place the highest value on the safety of healthcare professionals and patients.

*Wagner LK, Mulhern OR. Radiation–attenuating surgical gloves: effects of scatter and secondary electron production. Radiology. 1996;200(1):45�48

IMPORTANT: Radiation attenuation gloves are classified as a personal protective shield and are not a medical device. They must be used in combination with medical gloves if they come into contact with blood or other bodily fluids.

CAUTION: These radiation attenuation gloves are designed to protect hands from scattered radiation exposure originating from the X–ray beam during fluoroscopic procedures. They are not intended for use in direct or primary X–ray beams.

Specification:

Material: Polyisoprene with Tungsten
Powder Content: Powder Free
Colour: Black
Shape: Anatomic with Curved Fingers
Internal Glove Surface: Chlorinated
External Glove Surface: Textured Fingers
Cuff Style: Straight
Glove Thickness: Finger: Minimum 0.30 mm / Minimum 11.81 mils; Palm: Minimum 0.29 mm / Minimum 11.42 mils; Cuff: Minimum 0.30 mm / Minimum 11.81 mils
Glove Length: Typical 301 mm / 11.9 inches
Primary Skin Irritation: Considered negligible as per ISO 10993-10
Skin Sensitization: No evidence of delayed dermal contact sensitization as per ISO 10993-10
Protein Level: Not applicable, contains no natural rubber latex
Freedom From Holes (AQL): Manufacturing final release: 1.0 (Inspection level GI)
Sterilization Method: GAMMA irradiation (25 kGy)
Tested For Use With Chemotherapy Drugs: No, not tested in accordance with ASTM D6978
Viral Penetration: Pass (EN)
Product Standards: ASTM F2547, EN 61331-1
Quality / Environmental Standards: ISO 9001; ISO 13485; ISO 14001; ISO 11137-Part 1; EN 556
Product Certification: EU: PPE Regulation (EU) 2016/425 (Cat. III risks) US: 510K exempted as per 21 CFR 892.6500 / MDL # D367830
Shelf Life: 3 years
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.