No, this product is non-sterile and does not undergo Ethylene Oxide Sterilization.

What materials are used to make the mask?

It consists of three layers of polypropylene non-woven fabric with a galvanized iron wire nose clip.

Do you offer OEM and ODM services?

Yes, we provide OEM and ODM services including customization from samples, designs, and flexible options.

FDA 510 (K) En14683 Disposable Medical Face Mask

Name: FDA 510 (K) En14683 Disposable Medical Face Mask
Brand: Wellmien Healthcare Tech. (Suzhou) Co., Ltd.
SKU: 785079455

Jiangsu, ChinaWellmien Healthcare Tech. (Suzhou) Co., Ltd.

US$0.013

200,000-499,999 Pieces

US$0.0125

500,000-999,999 Pieces

US$0.012

1,000,000+ Pieces

Sample price:US$0.00/piece.Request sample

Product profile

Customization

Available

Type

Face Mask/Apron/Gloves

Material

Non-woven Fabric

Model NO.

WELLMIEN-FM005

Ethylene Oxide Sterilization

Without Ethylene Oxide Sterilization

Quality Guarantee Period

Two Years

Group

Adult & Child

Logo Printing

With Logo Printing

Size

Adult: 17.5*9.5cm / Child: 14.5*9.5cm

Layer

3ply

Style

Earloop

Color

White/Blue/Green/Yellow etc.

Nose Clip

Single Nose Wire/Double Nose Wire/Plastic Nose Cli

Sterile

Nonsterile

Certificate

Ce, ISO 13485, FDA 510(K)

Transport Package

50PCS/Box, 40boxs/CTN

Specification

Adult: 17.5*9.5cm; Child: 14.5*9.5CM

Trademark

WELLMIEN

Origin

Jingsu, China(Mainland)

HS Code

63079000

Production Capacity

9000000PCS/Month

Key features

FDA 510K & CE Certified: Complies with FDA 510K (K101000), CE, and ISO 13485 standards for medical use.

High Filtration Efficiency: BFE and PFE exceed 99% with Delta P under 6.0 for optimal breathing resistance.

Customizable Design: Offers customization for size, color, nose clip type, and logo printing.

ASTM Level 3 Performance: Meets ASTM F2100 Level 3 with 160mmHg synthetic blood penetration resistance.

Latex and Glass Fiber Free: Safe for sensitive users with no latex or glass fiber components.

Fast Production Lead Time: Standard production time is 10 days, with peak/off-season times within 15 workdays.

OEM and ODM Services: Full customization, minor customization, and design-based options available.

Two-Year Quality Guarantee: Comprehensive quality assurance period covering two years for all products.

Company profile

High Repeat Buyers ChoiceImporters and ExportersFast DeliveryFlexible Customization

Wellmien Healthcare Tech. (Suzhou) Co., Ltd.

Jiangsu, China

Business Type: Manufacturer/Factory, Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc.Export Year: 2006-05-15Nearest Port: Shanghai, Ningbo, ShenzhenAverage Response Time: ≤1.62h

AI-Powered supplier vetting

SummaryThe supplier is identified as a trading company with business activities covering medical and daily-use masks, protective equipment, textiles, outdoor products, plastic products, packaging, office supplies, and mechanical components. It reports broad customization, recent new-product development, ODM services, and OEM services for well-known brands. Export activity is substantial, with 90% of sales from exports, five years of export experience, and self-operated import/export rights. Documented procedures exist for supplier-service assessment, corrective and preventive actions, complaint handling, and finished-product inspection. However, the supplier reports no overseas warehouse, showroom, agent or branch, offline trade-show participation, or available SDK. Production capability is only partially evidenced because the company is classified as a trading company, although some manufacturing activities are listed.

After-Sales capabilityThe supplier has written and followed procedures for customer complaints, corrective and preventive actions, and service-capability assessment. However, it has no overseas warehouse, showroom, agent, or branch, and reports zero countries where overseas services are offered; this indicates documented service processes but limited overseas service infrastructure.

R&D capabilityThe supplier reports new products during the past year, ODM services, and broad R&D-related customization. However, it has no available SDK, so its innovation profile is positive for product development and design services but incomplete for SDK-based development.

Customization capabilityThe supplier explicitly offers customization from samples, customization from designs, full customization, minor customization, and flexible customization. These capabilities are consistently reported across the R&D and design-service records, providing clear evidence of broad customization support.

Client casesThe supplier reports providing OEM services for well-known brands, which is direct evidence of at least one type of customer engagement. No brand names, project details, product categories, volumes, or references are provided, so the breadth and verifiability of customer cases remain limited.