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UCHIKO-Disposable Face Mask

UCHIKO-Disposable Face Mask

Type: 3 layers, 4 layers

 

Intended use:

Face Mask can be used for the general public, including health care personnel (HCP) as personal protective equipment (PPE) in healthcare settings in accordance with CDC recommendations to cover nose and mouth.

Specifications:

  • Colors: Blue, White
  • Dimension (cm): 17.5 x 9.5
  • Weight (g): ≤ 10
  • Composition:

UCHIKO have been approved and certified by CE. 

 

Features

 

  • Perfect fitting and high breathability.
  • Lightweight, breathable and comfortable material.
  • Made and assembled in ISO 13485 Certified facility.
  • Made from materials that do not include any drugs or biologics.

 

 

Indications

Instruction for use:

  • Before putting on a mask, clean hands with alcohol-based hand rub or soap and water.
  • Cover mouth and nose with mask and make sure there are no gaps between your face and the mask.
  • Avoid touching the mask while using it; if you do, clean your hands with alcohol-based hand rub or soap and water.
  • Replace the mask with a new one as soon as it is damp and do not re-use single-use masks.
  • To remove the mask: remove it from behind (do not touch the front of mask); disard immediately in a closed bin; clean hands with alcohol-based hand rub or soap and water.
  • We disclaim any responsibility for possible consequences caused by improper use.

 

How to wear a mask:

 

 

Order Information

* Special note for the US market:

  • The product is not intended for:
  • Use as a surgical mask;
  • Use as a respiratory protective device;
  • Use in a clinical setting;
  • Antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses;
  • Use in high risk aerosol generating procedures.
  • The product has not been FDA cleared or approved.
  • The product has been authorized by FDA under an EUA for use as source control by the general public as well as by HCP in healthcare settings as to help prevent the spread of infection or illness during the COVID-19 pandemic.
  • This product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.

Test Report 

 

 

 

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