What is the lead time for mass production?

The average lead time is within 15 workdays for both peak and off-season periods.

Are these masks reusable?

No, they are disposable and recommended for single use, to be replaced every 4 hours.

What payment terms are accepted?

We accept LC, T/T, PayPal, D/P, Western Union, and small-amount payments.

FDA 510K/En14683 Surgical Face Masks

Name: FDA 510K/En14683 Surgical Face Masks
Brand: Wellmien Healthcare Tech. (Suzhou) Co., Ltd.
SKU: 709653802

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

US$0.015

200,000-499,999 Pieces

US$0.014

500,000+ Pieces

Sample price:US$0.00/piece.Request sample

Product profile

Customization

Available

Standard

EN14683-2019

Filter Rating

Normal

Model NO.

WELLMIEN-FM0035

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 & EN14683 Certified: Complies with USA FDA 510K and European EN14683-2019 standards for medical use.

High Filtration Efficiency: BFE and PFE both exceed 99%, ensuring effective protection against bacteria and particles.

Fluid Splash Resistance: Provides reliable protection against fluid splashes, suitable for healthcare environments.

Customizable Design: Offers full customization including size, logo printing, nose clip type, and material options.

Comfortable & Breathable: Made from non-woven fabric with adjustable earloops and nose clips for a secure fit.

Latex & Glass Fiber Free: Safe for sensitive skin, biocompatible, and free from latex and glass fibers.

Fast Sample Production: Existing samples available in 1 day; custom samples take 3-5 days for quick approval.

One-Stop OEM Service: Supports OEM/ODM requirements with professional shipping and after-sales service.

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: ≤1.60h

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.