Company Profile

Company Overview

Founded in 2006, Wellmien has grown to a company specializing in disposable medical supplies and Personal Protection Equipment (PPE), integrating with design, manufacture and sales capacity. Our sales headquarter is in Suzhou, Jiangsu and manufacturing plants cover a total area of 8,000m2 including 1,500m2 of clean room.


Wellmien provides globally medical care and food processing facilities with products including face masks, gowns, coveralls, aprons, bouffant caps, shoe covers, sleeve covers, under pads, disposable gloves, wound-care products, first-aid products and surgical packs etc. Our products are best sold to worldwide markets and widely applied to different settings such as hospitals, care centers, wholesalers, government agencies or institutes, food industries and households, etc. With excellent OEM services, our annual sales exceed 20 million USD.

15+

Years In The Field

1000+

Clients

100%

Customer Satisfaction

24hr

Online Service

Wellmien is ISO13485 certified and implements a strict Quality Management System (QMS). Our main products are approved by US FDA and EU CE certified. With superior products and services, our company has won the trust and support from new and old customers all over the world.

See the Documents

Our Certification

Picture Name Introduction Download
Wellmian Healthcare Suzhou FDA 2022.pdf Wellmian Healthcare Suzhou FDA 2022.pdf Wellmien has successfully updated the registration and listing information for 2022 with US FDA
CERT-Wellmien Healthcare.pdf CERT-Wellmien Healthcare.pdf Wellmien has obtained CE marking for Product.
ISO 13485.pdf ISO 13485.pdf Wellmien company has been ISO 13485:2016 certificated.
Test Report for SBP Resistance of ASTM Leve 3 surgical mask 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 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 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 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 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 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 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 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 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 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 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) 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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