PROFEEL® DHD™ POLYISOPRENE PF Surgical Gloves: The Latex-Free Alternative with Superior Comfort
Experience the exceptional comfort and performance of PROFEEL® DHD™ POLYISOPRENE PF Surgical Gloves. These sterile, powder-free gloves are crafted from a cutting-edge synthetic polymer, offering a latex-free alternative that delivers the feel and flexibility of natural rubber latex.
Key features and benefits:
- Suitable for latex-sensitive individuals: The 100% latex-free design eliminates the risk of allergies and irritation associated with natural rubber latex.
- Unparalleled comfort and dexterity: The proprietary synthetic polymer provides a soft, flexible fit that mimics the feel of natural latex, reducing hand fatigue during long procedures.
- Enhanced grip and control: The micro-textured surface ensures a secure grip on instruments, both wet and dry, allowing for precise control and tactile sensitivity.
- Advanced donning technology: The DHD™ (Damp-Hand-Donning) feature facilitates easy and comfortable donning even with damp hands.
- Reliable protection: The beaded cuff creates a secure seal with your gown, minimizing the risk of contamination, while the gloves are chemotherapy-tested for added protection.
PROFEEL® DHD™ POLYISOPRENE PF Surgical Gloves are the ideal choice for healthcare professionals seeking a latex-free alternative that delivers exceptional comfort, dexterity, and protection in the operating room.
Medical Device – Class IIa
Class IIa devices are subject to specific regulatory requirements, such as premarket review by a national regulatory agency, such as the FDA in the US, and MDR in the EU. Manufacturers of Class IIa devices must also comply with general safety and performance standards and must provide clinical data to demonstrate the safety and effectiveness of the device.
ISO 9001:2015 – Certified
We are a Denmark-based ISO 9001-certified medical device manufacturer, importer, and distributor. By following a strict QMS, we ensure that our clients always get the highest attention and the best quality products.
REACH
The REACH Regulation was introduced by the EU in 2007. Its aim is to improve the protection of people and the environment from the risks posed by chemicals. REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals.
Quality Standards
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EN 455-1:2020, EN 455-2015, EN 455-3:2015, EN 455-4:2009
EN 374-1:2016, EN 374-1:2016/A1:2018, EN 374-2:2019
EN 374-4:2019, EN 374-5 :2016. EN 16523-1:2015+A12018, EN420:2003+A1:2009 -
ISO 9001:2015, ISO 13485:2016, ISO 14001:2015
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Medical Device, Class IIa, in accordance to MDR 2017/745
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Personal protective equipment in accordance to Regulation (EU) 2016/425
CE Category III: For irreversible or mortal risks
Specifications
Thickness (mm) | Specification |
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Finger | 0.21 ± 0.03 |
Physical Properties | Unaged | Aged |
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Tensile Strength (MPa) | Min. 24 | Min. 18 |
Ultimate Elongation (%) | Min. 750 | Min. 560 |
Stress at 500% (MPa) | Max. 5.5 | N/A |
Force at break (N) | > 9 | > 9 |