Pindolife KN95 Facepiece Respirator
Pindolife KN95 Facepiece Respirator
Pindolife KN95 Facepiece Respirator
Pindolife KN95 Facepiece Respirator
Pindolife KN95 Facepiece Respirator

Facepiece Respirator

FFP2 FR-10

FFP2 FR-10 facepiece respirator is a Personal Protective Equipment designed and manufactured to be worn by a person for protection against risks that may cause very serious consequences such as death or irreversible damage to health relating to the following;

  • substances and mixtures which are hazardous to health;
  • harmful biological agents
Contact Us Declaration of Conformity document

Manufacturer Data

V-JOY Enterprise Co., Ltd
1500 Ling Mei Nan Street, HuShi Town, XiuYu District, PuTian City,
FuJian Province, China.

Device Description and Specification

Product trade name and model

Product: Facepiece Respirator
Brand: Pindolife
Model: FFP2 FR-10
Description: Pindolife Facepiece Respirator is disposable, for single use and non-sterile. The product is composed of an un-valved mask body, nose clip and mask ribbon.

Intended Use

FFP2 FR-10 facepiece respirator is a Personal Protective Equipment designed and manufactured to be worn by a person for protection against risks that may cause very serious consequences such as death or irreversible damage to health relating to the following;

  1. substances and mixtures which are hazardous to health;
  2. harmful biological agents;

The FFP2 FR-10 facepiece respirator has the function of covering the user's mouth, nose and jaw, providing a certain physical barrier to prevent the direct passage of pathogens, microorganisms and particles.

Intended users

FFP2 FR-10 facepiece respirator is intended for use by healthcare professionals in order to reduce the risk of the spread of infections, and it is not intended for use in an operating room or in other medical settings with similar requirements. This product is non-sterile.

Components and Materials

Design Flat fold with ear loops and adjustable nose band
Mask body built in 5 layers:
Outer: Spunbond nonwoven. Colour White (polypropylene)
Middle: Ethylene-Propylene Side By Side (ES) Thermal bonded nonwoven. Colour White (polypropylene + polyethylene)
Middle (filter): 2 layers of meltblown nonwoven. Colour White (polypropylene)
Inner: Spunbond nonwoven. Colour White (polypropylene)
Nose band: Aluminum
Ear Loops: Polyester and Spandex (non-latex)

Bio-compatibility

The materials that come into contact with the human body are the mask body, nose clip and mask ribbon. The mask body is made of non-woven fabric and melt-blown fabric. The nose clip is made of aluminum or polyethylene, and the mask ribbon is made of polyester, spandex or non-woven fabric. The raw material has been bioevaluated according to ISO10993 series standard, and there is no biocompatibility risk

Visual Identification

KN95-30

User Information

  • This filtering half mask is manufactured for COVID-protection only.
  • This filtering half mask is not a PPE device for general use and shall not be used for purposes other than protection against Covid-19
  • Check whether the package is in good condition before use, confirm the package identification, production date and validity period and use them within the validity period.
  • This is a single use product and shall not be used for more than 8 hours
  • This product is disposable and should be disposed as medical waste after use.
  • The nose clip on the mask should not be folded frequently to prolong the use time.
  • Please keep in cool dry place and out of the reach of children.
  • It is not recommended to wear this product when the air is not circulating, breathing is not smooth or while sleeping.
  • Children under three years old are not recommended because of their low vital capacity.
  • This product should not be used in a sterile surgical operation environment.
  • In case of liquid spillage, mask breakage, dampness and significant increase in respiratory resistance, please replace it in time.
  • Regulation and Technical Specifications:
    • Complies with PPE Regulation 2016/425 by means of Technical Specification 2020/403 – Masks for Healthcare workers
  • Notified Body for EU Type Examination (module B & C2)
    • BSI Group - NB 2797
      The Netherlands BV, Say Building, John M Keynesplein 9,
      1066 EP, Amsterdam, Netherlands
  • Manufacturer
    • V-JOY Enterprise Co., Ltd
      1500 Ling Mei Nan Street, HuShi Town, XiuYu District, PuTian City,
      FuJian Province, China.
      Email: info@pindolife.com

Directions of use:

Facing the inner side, pull the ear loops with both hands to stretch the mask and unfold it, with nose clip facing up
Make sure the mask covers the mouth, nose and jaw
Pull the elastic to the back of your ears and adjust it to feel as comfortable as possible
Put your fingertips on the top of the nose clip and press inward. Move your fingertips down along both sides of the nose clip, and then press the nose clip against the bridge of your nose.
Before entering the risk area, the user must check the tightness of the mask and face. If gas leakage is found please repeat steps 1 to 4

Marking

Masks will be marked at least with the following content

  • Manufacturer´s name, logo or registered trade mark
  • Model number
  • The characters FFP2 FR-10 as per norm EN149:2001 + A1:2009
  • CE Marking:
    • The CE marking shall consist of the initials ‘CE’ followed by the Notified Body number.
    • If the CE marking is reduced or enlarged, the proportions shall be respected.
    • The various components of the CE marking shall have substantially the same vertical dimension, which may not be less than 5 mm.
  • Example of minimum content to be marked on the mask. Layout or format may vary subject to commercial design.

EU Declaration of Conformity

This declaration of conformity is issued under the sole responsibilityof the manufacturer:

Manufacturer and address V-JOY Enterprise Co., Ltd
1500 Ling Mei Nan Street, HuShi Town, XiuYu District,
PuTian City, FuJian Province, China.
Product name Facepiece Respirator
Model/Series No. KN95-30
Techincal Reference: BSI's PPE Technical Specification for Healthcare professionals during Covid-19 Pandemic
Applicable Regulation: PPE Regulations 2016/425
Notified body for EU type-examination (Module C2) BSI Group - NB 2797
The Netherlands BV, Say Building,
John M Keynesplein 9,
1066 EP, Amsterdam, Netherlands
Certificate Number CE732642

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