Can you share any Corporate Giants that had worked with you?

NHS (the United Kingdom), Singapore (Guardian), TESCO (the United Kingdom), 72HRS (Canada), MCJ (USA), O&M (USA) etc.

FDA 510 (K) Disposable Surgical Face Mask Nonwoven Medical Mask

Name: FDA 510 (K) Disposable Surgical Face Mask Nonwoven Medical Mask
Brand: Wellmien Healthcare Tech. (Suzhou) Co., Ltd.
SKU: 712224342

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

US$0.018

200,000-499,999 Pieces

US$0.017

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-FM0018

Available Times

Disposable

Type

Face Mask/Apron/Gloves

Layers

3 Ply

Style

Earloop

Shape

Flat

Sterilization

Non Sterilization

Age Group

Adult

Color

as Customized

Usage

Laboratory, Clinic, Food Processing, Hospital, etc

Name

FDA Approval Medical Disposable Nonwoven Face Mask

Material

Non-woven Fabric

Certification

CE, FDA, ISO13485

Ethylene Oxide Sterilization

Without Ethylene Oxide Sterilization

Quality Guarantee Period

Three Years

Group

Both

Logo Printing

Customized

Transport Package

50PCS/Box, 40boxes/CTN

Specification

17.5X9.5cm(Adult); 14.5X9.5cm(Child)

Trademark

WELLMIEN or OEM

Origin

China, Jiangsu

HS Code

63079000

Production Capacity

9000000

Key features

FDA and CE Certification: Meets FDA 510K, ISO13485, CE, and EN14683 standards for global import.

High Filtration Efficiency: BFE and PFE both exceed 99% with synthetic blood penetration resistance of 160mmHg.

Customizable Colors: Available in blue, green, pink, purple, black, or fully customized per client request.

Custom Branding Options: Offers customized logo printing on masks and boxes, including full cartoon printing.

Breathable 3-Ply Design: Constructed with SBPP+MB+SBPP layers ensuring low breathing resistance and comfort.

Latex and Glass-Free: Safe for sensitive users with no latex or glass fiber content in materials.

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

Global Export Experience: Serves major clients like NHS UK, TESCO, and Guardian, exporting to Europe and beyond.

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: ≤2.60h

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 when I buy a mask for the first time?

Confirm the purpose of buying masks. Daily general protection: Nonwoven face mask (3ply, BFE>95%), KN95 mask, KF94 mask. Protection of anti-epidemic personnel: N99 mask, N95 mask. Hospital daily protection: L2/L3 Surgical Mask, Type IIR Surgical mask. Hospital operating room protection: L3 Surgical Mask, Type IIR Surgical mask, or surgical mask with face shield. Dust particle protection: N99 mask, N95 mask. Outdoor riding protection: Polyurethane mask.

Q:How to choose the mask size?

We offer sizes for both Adult and Children.

Q:Can you provide a different color face mask?

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

Q:Are you able to custom our box or mask design?

Definitely. Mask can be placed printing or cartoon full printing. Any artwork shared with us will be helpful. Box can be printed according to client design or designed by the Wellmien team as well.

Q:Do you have any certificates that can be allowed to import to European countries?

Yes, DOC (Declaration of Conformity), CE, and EN14683 standard SGS report. For example, Wellmien had exported surgical masks to Switzerland; France, Greece, the United Kingdom, etc. Documents meet European laws.