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Disposable Medical Face Masks

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Disposable Medical Face Masks, designed and manufactured to cover the wearers’ mouth, nose, and jaw, suitable for use in a general medical setting as a disposable face mask to block the exhalation or ejection of contaminants from the mouth and nose.

Description

Disposable medical face masks quick details:

Style:
Flat Ear-Loops Type
Material:
20-25g non-woven fabric.
Mask Size: 17.5 cm x 9.5 cm
Middle Filter :
 25g Meltblown Non-woven Fabrics
Sterilized:
 Yes

Disposable medical face masks, In China, should meet the standard:

YY/T 0969-2016 Disposable Medical Face Mask

Scope

This specification covers the technical requirements of disposable medical face masks, test methods, marking, and instructions for use and packaging, transportation, and storage.

This standard applies to single-use masks that cover the user’s mouth, nose, and jaw and are worn in a general medical setting to block exhaled or ejected contaminants from the mouth and nose.

This standard does not apply to medical protective masks and medical-surgical masks

 

Technical requirements  of disposable medical face masks

4.1 The appearance of the medical mask should be neat and in good shape, and the surface should not have any damage or stains.

4.2 Construction and size When worn, the disposable mask should be able to cover the wearer’s nose, mouth to the jaw. Shall conform to the design dimensions and allowable errors of the sign.

4.3 Nose Clips

4.3.1 The mask shall be equipped with a nose clip made of a plastic material.

4.3.2 The length of the nasal clip should not be less than 8.0 cm.

4.4 Medical Mask straps

4.4.1 The mask straps shall be easily accessible.

4.4.2 Each mask strap shall have a breaking force of not less than 10 N at the point of connection with the mask body.

4.5 Filtration Efficiency of Medical Face Mask

Bacterial Filtration Efficiency (BFE) The bacterial filtration efficiency of the mask shall be not less than 95%.

4.6 Differential pressure (Δp) The differential pressure (Δp) between the two sides of the mask for gas conversion should be no greater than 49 Pa.

4.7 Microbial indicators

4.7.1 Non-sterile masks shall meet the requirements of Table 1.

Total bacterial colonies

CFU/g

Coliforms Pseudomonas aeruginosa Staphylococcus aureus hemolytic streptococcus fungus
≤100 must not be detected must not be detected must not be detected must not be detected must not be detected

Table 1 Microbiological indicators of masks

4.7.2 Masks marked or illustrated with the words “sterile” or “sterile” on the package shall be sterile.

4.8 Ethylene oxide residue The ethylene oxide residue of a mask that has been sterilized with ethylene oxide shall not exceed 10 ug/g.

4.9 Biological Evaluation

4.9.1 Cytotoxicity The cytotoxicity of the mask should be no greater than grade 2.

4.9.2 Skin irritation The primary irritation index of the mask material shall not exceed 0.4.

4.9.3 Delayed hairstyle hypersensitivity The mask material should be less than 1 level.

Signs of the disposable medical masks package

The minimum package of the mask should have a clear Chinese logo, if the package is transparent, the logo should be visible through the package. The logo should include, at a minimum.

  1. Product name.
  2. Date of production and/or lot number.
  3. Name and contact details of the manufacturer.
  4. Implementation standard number.
  5. Product registration certificate number.
  6. Instructions for use.
  7. Storage conditions.
  8. The word or symbol “single-use”.
  9. In the case of sterilized products, the appropriate sterilization markings, indicating the sterilization method used and the expiration date.
  10. Specifications and allowable errors.
  11. Product use.

Instruction for use as medical single-use face masks

The instructions for use should give at least the following information.

Product name.

Name, address, and contact details of the medical face masks manufacturer.

Product use and use restrictions.

Inspections to be carried out before use.

Methods of use (including at least positive and negative identification and wearing methods).

Storage conditions.

Warnings or cautions.

The meaning of the symbols and/or diagrams used.

In the case of sterilized products, indicate the sterilization method used.

Important Notice

For anti-virus purpose, there is no need to buy these medical face masks for general public use, since disposable medical face masks need to be sterilized and store many days after production, this makes the lead time of disposable medical face masks much longer than non-medical disposable face masks, so please leave the medical face masks for the medical staff.

If you are planning to wholesale civil use flat 3 ply earloop disposable face masks instead of this Disposable Medical Face Masks, you can check our antiviral masks from the link below:

texinstru disposable face mask

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