Surgery

Secure Wear USA™ Surgical Face Masks

The Secure Wear USA™ Surgical Face Mask is designed to reduce the transfer of microorganisms, body fluids and particulate materials in patients and the healthcare professionals if worn properly. It covers the user’s nose and mouth. It is suggested to be disposed after each single-use.


Our Surgical Face Masks are designed to be flat-pleated with ear loop or tie-on design and are composed by three layers of polypropylene fabric. The outer and the inner layer are spunbond polypropylene and the middle layer is meltblown polypropylene. The nose piece made of steel wire covered with white polypropylene can be reinforced to fit tight above the nose. There are two options for the surgical mask to be secured on users via ear loops and ties.

Cleared by the Food & Drug Administration (FDA)

U.S. Based Manufacturer & Distributor

Tie On

The Secure Wear USA™ Tie On Surgical Face Mask is intended to be worn to protect both the patient and the healthcare professional from transfer of microorganisms, body fluids, and particulate material. The surgical face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device.

TieOn_Girl_Photo.png
Tie On_Graphic_Elements.png
Tie On_Graphic_Elements.png
Tie On_Graphic_Elements.png
Performing Surgery
SW, Table Data (5).png

Ear Loop

The Secure Wear USA™ Ear Loop Surgical Face Mask is intended to be worn to protect both the patient and the healthcare professional from transfer of microorganisms, body fluids, and particulate material. The surgical face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device.

Earloop_graphic_elements (1).png
Earloop_graphic_elements (1).png
Earloop_graphic_elements (1).png

Performance Levels:

Our surgical face masks models meet the performance levels of the ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks. 

  • Bacterial Filtration Efficiency (ASTM F2101-19)

  • Differential Pressure (EN 14683:2019, Annex C)

  • Sub-micron Particulate Filtration Efficiency (ASTM F2299)

  • Synthetic Blood Penetration Resistance (1862/F1862M-17)

  • Flammability (16 CFR Part 1610)

Biocompatibility:

We have conducted biocompatibility testing according to the ISO 10993 Standard Biological Evaluation of Medical Devices. The Cytotoxicity (ISO 10993-5) and Skin Irritation and Skin Sensitization (ISO 10993-10) test results demonstrate that our surgical face masks are biocompatible and safe for its intended use.

  • Non-Cytotoxic

  • Non-Irritating

  • Non-Sensitizing