Are the masks latex-free?

Yes, the masks are free from glass fiber and latex.

What is the blood penetration resistance level?

The masks meet ASTM Level 3 with a synthetic blood penetration resistance of 160mmHg.

What materials are used in the mask?

The mask consists of three layers of polypropylene non-woven cloth with a galvanized iron wire nose clip.

FDA 510 (K) En 14683 Custom Printed Disposable Surgical Face Mask

Name: FDA 510 (K) En 14683 Custom Printed Disposable Surgical Face Mask
Brand: Wellmien Healthcare Tech. (Suzhou) Co., Ltd.
SKU: 709653882

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

US$0.025

200,000-499,999 Pieces

US$0.021

500,000-999,999 Pieces

US$0.019

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-FM082

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

FDA 510K & CE Certified: Complies with FDA 510K (No:K101000), CE, and ISO13485 standards for medical safety.

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

Customizable Logo Printing: Offers logo printing services for personalized branding on surgical masks.

Latex and Glass-Free: Manufactured without glass fiber or latex to prevent allergic reactions.

Flexible Customization Options: Supports full customization, minor customization, and customization from samples or designs.

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

Durable Nose Clip Design: Features galvanized iron wire nose clips for a secure and comfortable fit.

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: ≤2.29h

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.