Wholesale ASTM F1862 Tie-on Surgical Face Mask – >99% BFE/PFE, FDA 510(k) Approved Fluid-Resistant

Description

Wholesale ASTM F1862 Tie-on Surgical Face Mask – Certified Fluid Resistance and >99% Filtration for the Operating Room

The Disposable 3-Ply Nonwoven Surgical Face Mask with Tie on is the premium barrier solution for high-risk medical environments, particularly operating rooms and procedural areas where exposure to fluids is a primary concern. This mask is rigorously tested and possesses the critical certifications necessary for surgical use, including FDA 510(k) Approval for Surgical Use and verification against the severe ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood. The construction is a meticulous multi-ply nonwoven material structure offering a dual function: superior protection combined with the lightness of fit and breathability required for extended wear. Procurement teams focused on the highest standards of protection and regulatory compliance must specify this caliber of surgical mask.

Compliance That Guarantees Performance: FDA and ASTM F1862

The certification and testing of this surgical face mask confirm its designation for the most critical procedures:

• FDA 510(k) Surgical Approval: This regulatory clearance is essential, designating the mask as a Class II medical device cleared for use in surgical settings. This assures buyers that the mask meets the specific safety and efficacy standards required to protect both the patient and the healthcare worker in the operating theater.
• ASTM F1862 Fluid Resistance: This test is the defining factor for a true fluid-resistant surgical mask. It subjects the mask to a standardized spray of synthetic blood at high velocity to determine the resistance of the mask’s material to penetration. Compliance with ASTM F1862 means the mask provides a proven, robust barrier against potential exposure to bloodborne pathogens and large-volume fluid splash incidents, which are common in many surgical specialties. This feature is the most critical differentiator from basic procedure masks.
• Superior Filtration Efficiency: The mask is engineered with a Bacterial and Particulate Filtration Efficiency (BFE/PFE) of >99%. This exceeds the requirements for Type II R masks (the European equivalent), ensuring maximum reduction of microbial and particulate aerosols traveling both in and out of the mask. The high BFE is a function of the middle layer, which is typically a high-efficiency meltblown material, while the PFE confirms the mask’s ability to filter non-viable particles for overall environmental protection.

Design Features for Optimal OR Use

The design of the 3-ply surgical mask is optimized for sterility and comfort during complex procedures:

• Nonwoven Tie-on Closure: The inclusion of nonwoven ties ensure a custom fit during use. Unlike elastic ear loops, which can create pressure points or cause gaps due to varying head sizes, the tie-on mechanism allows for a superior, adjustable fit secured over the surgical cap or hood. Crucially, the tie-on design enables the mask to be removed without touching the front – a critical sterile protocol for safe doffing and minimizing the risk of self-contamination after exposure to the operative environment.
• 3-Ply PPSB Structure: The mask is constructed with a 3-ply layering: two layers of soft, durable polypropylene spunbond (PPSB) material flanking a central bacterial filtration material. This structure provides an ideal combination of good barrier protection and low breathing resistance, making the mask cool and comfortable, ideal for extended wear in lengthy procedures.
• Enhanced Comfort Details: The mask is built with ultrasonic bonding for enhanced durability (eliminating stitched seams that can tear) and features a specialized, extra-soft nose bridge. This superior nose bridge material, often foam or a cushioned metal strip, provides added comfort for all facial shapes while ensuring a precise, customized seal around the nasal area, preventing dangerous gapping.
• Hypoallergenic Assurance: This mask is 100% latex-free, making it safe for use by all medical personnel and patients, removing the risk of Type I hypersensitivity reactions in the healthcare environment.

For B2B purchasers managing the inventory for surgical, cardiac, trauma, and high-risk procedural units, the Wholesale ASTM F1862 Tie-on Surgical Face Mask is not just a choice, but a regulatory and safety necessity that meets the highest standards for both fluid and particle barrier protection.