Can you share corporate clients you have worked with?

Yes, our clients include NHS (UK), Guardian (Singapore), Tesco (UK), 72HRS (Canada), MCJ (USA), and O&M (USA).

What is the minimum order quantity?

The Minimum Order Quantity is 10,000 PCS.

What are the payment terms?

We accept LC, T/T, PayPal, D/P, Western Union, and Small-amount payment.

High Quality FDA 510k Clear Surgical Masks

Name: High Quality FDA 510k Clear Surgical Masks
Brand: Wellmien Healthcare Tech. (Suzhou) Co., Ltd.
SKU: 709651152

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

US$0.015

200,000-499,999 Pieces

US$0.0135

500,000-999,999 Pieces

US$0.012

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-FM007

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: Compliant with FDA 510k, CE, ISO13485, and EN14683-2019 standards for global import.

High Filtration Efficiency: 3-ply SBPP+MB structure with BFE>95%, offering low resistance and super breathability.

Customizable Design: Supports custom colors, logo printing, and packaging design based on client artwork.

Versatile Protection Levels: Available in L2/L3 Surgical, N95, and N99 masks for hospital, epidemic, and daily use.

Trusted by Global Giants: Supplied to major clients like NHS, Tesco, Guardian, and MCJ across multiple countries.

Flexible OEM/ODM Service: Full customization options including samples, designs, and minor adjustments available.

Fast Production Lead Time: Standard production takes 10-20 days depending on quantity, with peak/off-season consistency.

Two-Year Quality Guarantee: Comprehensive quality guarantee period ensuring product reliability and customer trust.

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.

Product Q&A

Q:How to choose a suitable mask for the first time?

For daily protection, choose 3ply Nonwoven (BFE>95%), KN95, or KF94. For anti-epidemic personnel, use N99 or N95. For hospital daily use, select L2/L3 Surgical or Type IIR. For operating rooms, use L3 Surgical, Type IIR, or masks with face shields. For dust protection, choose N99 or N95. For outdoor riding, use Polyurethane masks.

Q:How to choose the mask size?

Masks are available in Adult and Children sizes.

Q:Can you provide different color face masks?

Yes, blue is the most common, but we also offer pink, purple, black, etc., or as per client requests.

Q:Are you able to customize box or mask design?

Definitely. Masks can have printing or cartoon full printing. Any artwork shared is helpful. Boxes can be printed according to client design or designed by our team.

Q:Do you have certificates for importing to European countries?

Yes, we provide DOC (Declaration of Conformity), CE, and EN14683 standard SGS reports. We have exported to Switzerland, France, Greece, and the UK, meeting European laws.