FDA 510 (K) En 14683 3-Ply Custom Disposable Surgical Face Mask

Name: FDA 510 (K) En 14683 3-Ply Custom Disposable Surgical Face Mask
Brand: Wellmien Healthcare Tech. (Suzhou) Co., Ltd.
SKU: 709652822

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

US$0.02

200,000-499,999 Pieces

US$0.018

500,000-999,999 Pieces

US$0.015

1,000,000+ Pieces

Sample price:US$0.00/piece.Request sample

Product profile

Customization

Available

Standard

EN14683-2019

Filter Rating

Normal

Model NO.

WELLMIEN-FM0045

Available Times

Disposable

Type

Face Mask/Apron/Gloves

Layers

3 Ply

Style

Earloop

Shape

Flat

Sterilization

Non Sterilization

Age Group

Adult

Color

White/Blue/Green/Yellow etc.

Size

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

Layer

3ply

Nose Clip

Single Nose Wire/Double Nose Wire/Plastic Nose Cli

Certificate

Ce, ISO 13485, FDA 510(K)

Sterile

Nonsterile

Material

Non-woven Fabric

Certification

CE, FDA, ISO13485

Ethylene Oxide Sterilization

Without Ethylene Oxide Sterilization

Quality Guarantee Period

Two Years

Logo Printing

With Logo Printing

Group

Adult & Child

Transport Package

50PCS/Box, 40boxs/CTN

Specification

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

Trademark

WELLMIEN or OEM

Origin

Jingsu, China(Mainland)

HS Code

63079000

Production Capacity

9000000PCS/Month

Key features

EN14683 Type IIR Certified Protection Manufactured in accordance with EN14683 Type IIR standards, this disposable surgical face mask provides reliable bacterial filtration and fluid resistance.

Comfortable 3-Ply Non-Woven Structure Made of high-quality non-woven fabric with a three-layer design, the medical face mask offers excellent breathability and filtration efficiency.

Secure Fit with Soft Earloops Designed with elastic earloops and an adjustable nose clip, the disposable surgical face mask provides a comfortable and secure fit for different face shapes.

Widely Used in Medical & Industrial Applications Suitable for hospitals, clinics, laboratories, dental practices, pharmaceutical manufacturing, food processing and cleanroom environments.

OEM & Private Label Service Support customized colors, packaging, printing, logo, carton design, and private label solutions for distributors, wholesalers and healthcare brands worldwide.

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: ≤2.38h

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.

Product Q&A

Q:What standard does this surgical face mask comply with?

This disposable surgical face mask complies with EN14683 Type IIR, providing high bacterial filtration efficiency and splash resistance for medical applications.

Q:What material is used in the mask?

The medical face mask is made from a 3 ply non woven structure, including two layers of polypropylene non woven fabric and one high-efficiency meltblown filter layer.

Q:Is this face mask suitable for hospital use?

Yes. The EN14683 Type IIR surgical face mask is widely used in hospitals, clinics, dental practices, laboratories and other healthcare environments requiring reliable protection.

Q:Can you provide OEM and private label services?

Yes. We support OEM manufacturing, customized packaging, logo printing, private label branding, color customization and carton design for distributors and wholesalers.