Document Library

3-Ply Procedural Mask Spec Sheets

We provide 3 levels of procedural masks to cater to all of your needs. They provide protection for low to heavy amount of fluid, spray, and/or aerosols. Our masks were designed to be worn for long periods of time with strong support and a proper fit.

UP-01 Procedural Mask Spec Sheet

UP-01 ASTM F2100 Nelson Lab Test Report

EN14683 Type IIR Test Report

UP-02 Medical Mask Spec Sheet

EN14683 Type IIR Test Report

UP-03 Medical Mask Spec Sheet

UP-03 ASTM F2100 Fluid Resistance

UP-03 ASTM F2100 Breathability Report

Skin Sensitivity Testing

Upside Health Inc. tests our masks internationally and domestically to ensure the utmost safety and compliance. We will never mislead customers by referencing incomparable GTTC Chinese lab testing with significant variance in results and missing test methods. We’re here to supply the highest quality masks, in compliance with the highest standards.

ISO 10993-10 Skin Irritation Test Report

ISO 10993-5 In Vitro Cytotoxicity Test Report

Medical Device Manufacturing Certificates

Our certifications ensure the implementation of the highest level of medical device Quality Management System. By testing our raw materials and final goods, we can guarantee that our products meet our high standards every time. These certifications help us reinforce our commitment to top-level service and quality compliance.

ISO 9001 Certification

ISO 13485 Certification

Miscellaneous Documents

Upside Health Product Liability Insurance

Upside Health Purchase Terms and Conditions

Additional Links

Upside Health Inc. FDA Establishment Registration
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=247619
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Upside Health Inc. LYU Device Listing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=685735&lpcd=LYU
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Upside Health Inc. QKR Device Listing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=685831&lpcd=QKR
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Upside Health Inc. FXX Device Listing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=691374&lpcd=FXX5)
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Upside Health Inc. Contract Manufacturer FDA Establishment Registration
‍https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=274122
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Upside Health Inc. Contract Manufacturer FXX Device Listing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=695187&lpcd=FXX
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Upside Health Inc. Contract Manufacturer QKR Device Listing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=666324&lpcd=QKR
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Upside Health Inc. Contract Manufacturer LYU Device Listing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=651884&lpcd=LYU

Contact us for a free compliance consultation about your current mask supplier.

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sales@enjoyupside.com

2323 Main St. Irvine, CA 92614