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Quality Manageament System

Wellmein has built a quality management system for the product process at every stage, to make sure all the products comform to the Standard.

Product Quality Control Process

This video shows how Wellmien mass produces the face masks.

01Raw materials

  • Receiving Materials
  • Inspecting Materials
  • Storing Materials
02Mask production
  • Feeding Materials
  • Folding
  • Welding and Cutting
  • Ear Band Welding
  • Inspection
03Mask production
  • Inner Bag Coding
  • Box Coding
  • Packaging
04Mask production
  • Product Inspection
  • Storing Finished Goods
Our Certification
Picture
Name
Introduction
Download
Wellmian Healthcare Suzhou FDA 2023.pdf

这是测试文本，单击 “编辑” 按钮更改此文本。

CERT-Wellmien
Healthcare.pdf
Wellmien has obtained CE marking for Product.
ISO 13485.pdf
Wellmien company has been ISO 13485:2016 certificated.
Test Report for SBP
Resistance of ASTM Leve 3
surgical mask

Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 3

Synthetic Blood Penetration Resistance
Test Report for Delta P of ASTM Leve 3 surgical mask

Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 3

Differential Pressure (Delta P)
Test Report for BFE of ASTM Leve 3 surgical mask

Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 3

Bacterial Filtration Efficiency (BFE)
Test Report for PFE of ASTM Leve 3 surgical mask

Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 3

Particle Filtration Efficiency (PFE)
Test Report for SBP
Resistance of ASTM Leve 2 surgical mask
Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2
Synthetic Blood Penetration Resistance
Test Report for Delta P of ASTM Leve 2 surgical mask
Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2
Differential Pressure (Delta P)
Test Report for BFE of ASTM Leve 2 surgical mask
Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2
Bacterial Filtration Efficiency (BFE)
Test Report for PFE of ASTM Leve 2 surgical mask
Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2
Particle Filtration Efficiency (PFE)
Test Report for PFE of ASTM Leve 2 surgical mask
Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2
Particle Filtration Efficiency (PFE)
Test Report for SBP Resistance of Type IIR Mask
Test report from Nelson Labs for Wellmien medical mask EN14683:2019 Type IIR
Synthetic Blood Penetration Resistance
Test Report for BFE&Delta P of TYPE IIR mask
Test report from Nelson Labs for Wellmien medical mask EN14683:2019 TYPE IIR

Bacterial Filtration Efficiency (BFE)
and Differential Pressure (Delta P)

Test Report for BFE&Delta P of TYPE II mask
Test report from Nelson Labs for Wellmien medical mask EN14683:2019 TYPE II

Bacterial Filtration Efficiency (BFE)
and Differential Pressure (Delta P)

FDA 510K for Wellmien Surgical Mask (No. K101000)
Wellmien surgical mask was approved by FDA 510K in 2010.
FDA510K number: K101000
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