The Surgical Face Mask comprises the mask body, nose clip, and mask straps. The mask body is tri-layered, consisting of inner, middle, and outer layers. The inner and outer layers are crafted from polypropylene non-woven fabric, while the middle layer is composed of polypropylene melt-blown fabric. The ear-loop material is a blend of polyester and spandex. The product is sterile and designed for single use.
A surgical face mask, also known as a medical or surgical face mask, is designed to cover the user’s nose, mouth, and chin, providing a physical barrier against pathogens, microorganisms, bodily fluids, and particles. This article outlines the essential technical requirements to guarantee the effectiveness and safety of surgical masks.
General Specifications of Surgical Face Mask:
Surgical face masks should have a neat appearance with an intact shape, free from damage or stains. Proper fit is crucial, covering the wearer’s nose, and mouth, and extending to the chin. The design dimensions and tolerances must adhere to specified standards. The mask should include a pliable nose clip made of plastic, with a length not less than 8.0cm. Convenient strap attachment is required, with each strap having a minimum breaking force of 10N at the connection point with the mask body.
Fluid Resistance and Filtration Efficiency:
After exposure to 2mL synthetic blood at a pressure of 16.0 kPa (120 mmHg), the mask’s inner side should not show signs of penetration. The bacterial filtration efficiency (BFE) should be no less than 95%, and the particle filtration efficiency (PFE) for non-oily particles should be at least 30%. The pressure differential (ΔP) for gas exchange on both sides of the mask should not exceed 49Pa.
Fire Resistance and Ethylene Oxide Residue:
Surgical mask materials must be flame-resistant, burning for no more than 5 seconds after leaving the flame. For masks sterilized with ethylene oxide, the residual amount should not exceed 10 μg/g.
Biocompatibility:
The primary irritation index of mask materials should not surpass 0.4, and cytotoxicity should be no greater than level 2. Surgical mask materials should not induce delayed hypersensitivity reactions.
Labeling Requirements:
Labels must include product name, production date and/or batch number, manufacturer’s name and contact information, standard number, product registration number, usage instructions, storage conditions, indication of “single-use,” sterilization symbols if applicable, specifications and tolerances, and product purpose.
Packaging:
Masks must be packaged to prevent mechanical damage and pre-use contamination. They should be packed in quantities.
Advantages of Surgical Face Mask:
a. High Filtration Efficiency: Engineered to filtrate a high percentage of airborne particles, ensuring optimal protection.
b. Breathability: Despite its robust filtration capabilities, the mask allows for easy and comfortable breathing, reducing wearer fatigue.
c. Secure Fit: The elastic ear loops and adjustable nose bridge ensure a snug and secure fit for every user.
d. Hypoallergenic Design: The hypoallergenic inner layer minimizes the risk of skin irritations, catering to sensitive skin.
e. Fluid Resistance: The outer layer provides an effective shield against bodily fluids, enhancing overall protection.
In a world where health and safety are paramount, our Surgical Face Mask stands as a testament to cutting-edge design and unwavering protection. Choose confidence, choose safety – choose our Surgical Face Mask.
JINYE is a company that specializes in PPE products customization and solutions .
With years of experience in the industry, we offer a wide range of disposable protective items, including masks, gloves, and gowns. Our commitment to excellence and customer satisfaction sets us apart, making us the preferred choice for buyers worldwide.