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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 headquarters is in Suzhou, Jiangsu, and manufacturing plants cover a total area of 8,000m2 with 1,500m2 clean rooms.

Wellmien is devoted to providing global medical care and food processing facilities with products, such as face masks, gowns, coveralls, aprons, bouffant caps, shoe covers, sleeve covers, underpads, disposable gloves, wound-care products, first-aid products, surgical packs, etc. Our products are sold well to worldwide markets and widely applied to settings such as hospitals, care centers, wholesalers, government agencies or institutes, food industry householders, etc. With excellent OEM services, our annual sales exceed 20 million USD.

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

Our Certification

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Wellmien has successfully updated the registration and listing information for 2024 with US FDA

Wellmien has obtained CE marking for Product.

Wellmien company has been ISO 13485:2016 certificated.

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

Synthetic Blood Penetration Resistance

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

Differential Pressure (Delta P)

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

Bacterial Filtration Efficiency (BFE)

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

Particle Filtration Efficiency (PFE)

Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2

Synthetic Blood Penetration Resistance

Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2

Differential Pressure (Delta P)

Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2

Bacterial Filtration Efficiency (BFE)

Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2

Particle Filtration Efficiency (PFE)

Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2

Particle Filtration Efficiency (PFE)

Test report from Nelson Labs for Wellmien medical mask EN14683:2019 Type IIR

Synthetic Blood Penetration Resistance

Test report from Nelson Labs for Wellmien medical mask EN14683:2019 TYPE II

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

Test report from Nelson Labs for Wellmien medical mask EN14683:2019 TYPE IIR

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

Wellmien surgical mask was approved by FDA 510K in 2010.

FDA510K number: K101000