Our Masks

UPSIDE™ PROCEDURAL MASKS

Our ASTM Level 1 Masks are ideal for procedures where light to moderate amounts of fluid, spray and/or aerosols are produced. The ear loops are molded in on both sides providing strong support. The adjustable nosepiece allows for comfortable and proper fit.

Level 1 Spec Sheet

Our ASTM Level 2 Masks are ideal for procedures where moderate to heavy amounts of fluid, spray and/or aerosols are produced. The ear loops are molded in on both sides providing strong support. The adjustable nosepiece allows for comfortable and proper fit.

Level 2 Spec Sheet

Our ASTM Level 3 Masks are ideal for procedures where heavy amounts of fluid, spray and/or aerosols are produced. The ear loops are molded in on both sides providing strong support. The adjustable nosepiece allows for comfortable and proper fit.

Level 3 Spec Sheet

PACKAGE FEATURES

cGMP Facility
All manufacturing, sterilization (custom ordered), and packaging are conducted at our cGMP manufacturing and packing facility to ensure quality control and sanitary conditions are met. Products leave our facility as final goods ready to be used by healthcare providers.
Mask Dispenser
UPSIDE™ Procedural Mask’s are packaged with end-users in mind. Our 50-piece boxsets have tearaway tops that allow our customers to dispense single masks without removing additional masks.
Airtight Sealing
Airtight Box Seal: Unlike traditional or alternative face mask packaging, UPSIDE™ Procedural Mask’s 50-piece boxsets are fully sealed off the production line. This fosters a better storage environment for the face mask’s shelf life while also ensuring ease of use when paired with our mask dispensing mechanism.

Certifications

U.S. Testing

All of our ASTM F2100 Standard testing was conducted here in the United States prior to approval by the FDA. We will never mislead customers by referencing incomparable GTTC Chinese lab testing with significant variance in results and missing test methods (like PFE testing).

ISO 13485

ISO13485 certification ensures implementation of the highest level of medical device Quality Management System. From internal testing of raw materials to retesting of final goods, ISO13485 ensures our products meet our high standards every time.

ISO 9001

ISO9001 certification is based on continuous quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. ISO9001 reinforces our commitment to top-level service and quality compliance.

FDA Compliance

In addition to our compliant marketing of FXX Class II Medical Devices, all manufacturing and packaging are done at our cGMP facility. With a 510(k), our products can safely be supplied to healthcare facilities with strict QMS protocols. We’re here to supply the highest quality masks, in compliance with the highest standards.

What makes our medical masks different

Premarket 510(k) :
The premarket submission made to the FDA demonstrate that the device is safe, effective, and ready to be legally marketed within the United States. A 510(k) signifies a formal mark of approval by the FDA and Health Department that the medical device is cleared for the American people. Medical devices– more specifically face masks-- without a 510(k) have NOT been approved by the FDA. (Having the FDA logo on the packaging does not mean it has a 510(k) nor does it mean it is approved– in fact, it is illegal to have the FDA logo on any medical device packaging).

FXX Product Code:
Heavily regulated product code designation of the FDA that requires premarket approval. The review process is conducted by Surgical and Infection Control Device & Infection Control and Plastic Surgery Device agencies within the Health Department. FXX is a permanent designation unlike the temporary COVID19 QKR product code. Additionally, FXX is heavily regulated for quality and performance unlike LYU or KHA product codes.