SourcingAI
Try for free
Powered by Made-in-China.com
Disposable High Quality FDA 510K Earloop Surgical Face Masks
US$0.019
200,000-499,999 Pieces
US$0.018
500,000-999,999 Pieces
US$0.017
1,000,000+ Pieces
Sample price:US$0.00/piece.Request sample

Product profile

Customization

Available

Type

Face Mask/Apron/Gloves

Material

Non-woven Fabric

Model NO.

WELLMIEN-FM003

Ethylene Oxide Sterilization

Without Ethylene Oxide Sterilization

Quality Guarantee Period

Three Years

Group

Adult & Child

Logo Printing

With Logo Printing

Size

Adult: 17.5*9.5cm / Child: 14.5*9.5cm

Layer

3ply

Style

Earloop

Color

White/Blue/Green/Yellow etc.

Nose Clip

Single Nose Wire/Double Nose Wire/Plastic Nose Cli

Certificate

Ce, ISO 13485, FDA 510(K)

Sterile

Nonsterile

Transport Package

50PCS/Box, 40boxs/CTN

Specification

Adult: 17.5*9.5cm; Child: 14.5*9.5CM

Trademark

WELLMIEN

Origin

Jingsu, China(Mainland)

HS Code

63079000

Production Capacity

9000000PCS/Month

Key features

FDA 510K Clearance: Approved by FDA with registration number K101000 for surgical use.
Multiple Color Options: Available in white, blue, green, yellow, or as requested.
Customizable Nose Clips: Options include single/double nose wire, plastic, or aluminum clips.
OEM/ODM Services: Full customization, design-based, and sample-based customization available.
High Filtration Efficiency: BFE and PFE exceed 98-99% depending on the specific type.
ISO 13485 Certified: Manufactured in a 1500 m2 cleanroom with certified quality management.
Fast Sampling: Existing samples ready in 1 day; custom design samples in 3-5 days.
Flexible MOQ: Minimum Order Quantity is 10,000 pieces.

Company profile

Wellmien Healthcare Tech. (Suzhou) Co., Ltd.
High Repeat Buyers ChoiceImporters and ExportersFast DeliveryFlexible Customization
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: ≤2.58h

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:What certifications does the mask have?
A:
The masks are FDA 510K approved (No: K101000), CE certificated, and ISO 13485 certified.
Q:Can I customize the color of the masks?
A:
Yes, colors include white, blue, green, yellow, or can be customized as requested.
Q:What are the available nose clip options?
A:
Options include single nose wire, double nose wire, plastic nose clip, and aluminum nose clip.
Q:What is the minimum order quantity?
A:
The minimum order quantity is 10,000 pieces.
Q:How long does it take to get a sample?
A:
Existing samples take 1 day, while samples based on your design take 3-5 days.

Send Inquiry

*To:Wellmien Healthcare Tech. (Suzhou) Co., Ltd.Wellmien Healthcare Tech. (Suzhou) Co., Ltd.
*Content:
0/4000

Supplier replies will be sent to your registered email

You may also like

High Quality Disposable Nonwoven Medical Earloop Face Masks
Made-in-China.com
High Quality Disposable 3ply Surgical Medical Face Mask
Made-in-China.com