What are the payment terms?

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

Are samples available?

Yes, we offer free samples upon request.

What is the material composition?

The masks are made of fiberglass-free and latex-free non-woven fabric.

Surgical Mask with FDA 510k

Name: Surgical Mask with FDA 510k
Brand: Wellmien Healthcare Tech. (Suzhou) Co., Ltd.
SKU: 709430982

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

US$0.05-0.08

200,000 Pieces

Sample price:US$0.00/piece.Request sample

Product profile

Customization

Available

Standard

EN14683-2019

Filter Rating

Normal

Model NO.

FM-16327-6

Available Times

Disposable

Type

Face Mask/Apron/Gloves

Layers

3 Ply

Style

Earloop

Shape

Flat

Sterilization

Non Sterilization

Age Group

Adult

Color

Blue, Green, White, Pink

Place of Origin

Jiangsu, China

Brand Name

Composition

Fiberglass Free and Latex Free

Size

17.5*9.5cm;14.5*9.5cm

Classify

Surgical Mask with FDA 510k

Application

Hospital, Clinic, House, Food Processing Place

Certification

CE, FDA

Ethylene Oxide Sterilization

Without Ethylene Oxide Sterilization

Logo Printing

With Logo Printing

Quality Guarantee Period

Five Years

Group

Adult or Children

Material

Non-Woven Fabric, Nonwoven Fabric

Transport Package

50PCS/Box, 40boxes/CTN, 50PCS/Bag, 40bags/CTN

Specification

CE/ISO13485

Trademark

Origin

Jiangsu, China(Mainland)

HS Code

6307900090

Production Capacity

10, 000, 000 PCS / Month

Key features

FDA 510k & CE Certified: Meets EN14683 Type IIR standards with FDA 510k approval for high-risk environments.

High Filtration Efficiency: Bacterial filtration efficiency (BFE) exceeds 99% with 120mmHg blood penetration resistance.

Safe Material Composition: Made from fiberglass-free and latex-free non-woven fabric for sensitive users.

Customizable Sizes: Available in adult (17.5x9.5cm) and children (14.5x9.5cm) sizes or as required.

Flexible Style Options: Offered in earloop or tie-on styles with adjustable metal nose bars.

OEM/ODM Services: Full customization available including logo printing and design modifications.

Rapid Delivery: Standard delivery time is 15 days for both peak and off-peak seasons.

Comprehensive Warranty: Five-year quality guarantee period covering mechanical defects.

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.