Sterile Surgical Face Mask FDA 510K Approved ASTM Level 2 Model TDM-A2

Name: Sterile Surgical Face Mask FDA 510K Approved ASTM Level 2 Model TDM-A2
Brand: Guizhou Tedia Medical Instruments Co., Ltd.
SKU: 2169361932

Guizhou, ChinaGuizhou Tedia Medical Instruments Co., Ltd.

US$0.01-0.022

10,000 Pieces

Sample price:US$1.00/piece.Request sample

Product profile

Customization

Available

Standard

YY 0469-2011

Filter Rating

≥98%

Model NO.

TDYXMASK

Available Times

Disposable

Type

Medical Surgical Mask

Layers

3 Ply

Style

Earloop

Shape

Flat

Sterilization

Age Group

Adult

Color

Blue

Logo

OEM

Sample

Freely

Certificate

ISO13485/CE/FDA

OEM

Accepted

Transport Package

Carton

Trademark

Tedia

Origin

Guizhou

HS Code

6307900010

Production Capacity

500000

Key features

FDA 510K Approved: Model TDM-A2 holds FDA 510K approval for medical use.

ASTM Level 2 Certified: Meets ASTM Level 2 standards for fluid resistance and filtration.

Comfortable Ear Straps: High-elastic latex-free straps prevent ear strangulation during long wear.

Breathable Design: Breathable resistance is less than 49kpa for smooth breathing.

Droplet Protection: Blocks droplets, pollen, and bacteria effectively.

OEM Logo Customization: Logo customization is accepted for OEM orders.

Free Sample Available: Samples are provided freely for customer evaluation.

Company profile

Management CertificationProduct CertificationStandardized quality controlHigh Repeat Buyers Choice

Guizhou Tedia Medical Instruments Co., Ltd.

Guizhou, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 7 Years CertifiedNearest Port: Shenzhen Port, Shanghai PortAverage Response Time: ≤8.83h

AI-Powered supplier vetting

SummaryThe supplier demonstrates broad customization, OEM/ODM service, in-stock capability, and established quality and product compliance certifications. It exports 21%–30% of sales and has seven years of export experience, but overseas service coverage is limited: no overseas agents, branches, warehouses, showrooms, or listed service countries. Quality, complaint-handling, corrective-action, and supplier-assessment procedures exist, yet written records are absent in several areas. Production-related evidence includes multiple automated production lines and a stated one-month peak-season fulfillment time, while the lack of a valid manufacturing-capacity contract with affiliated subcontractors is a structural concern. Financial information is limited to year labels without performance values, so credibility cannot be fully assessed. Innovation evidence is mixed: ODM and extensive design services are available, but no new products were reported in the past year and no SDK is available.

Supplier typeThe supplier provides OEM and ODM services, offers extensive customization, maintains in-stock capability, and operates or is associated with multiple production lines including packing, blood vessel collection, blood needle, anticoagulation, bed sheet, and automatic cap assembly lines. However, the absence of a valid manufacturing-capacity contract with affiliated subcontractors indicates a documented production-relationship gap.

CertificationsThe supplier reports an ISO9001:2015 management-system certificate and CE product compliance certification. These are explicit certifications supporting quality-system and product-compliance capability.

After-Sales capabilityService procedures exist for corrective and preventive actions, customer complaints, and supplier-service assessment, but written records are absent. The supplier has no overseas agents, branches, warehouses, showrooms, or listed overseas service countries, although it has attended CMEF and offers stock service.

Production capacityThe supplier reports in-stock capability, multiple automated or specialized production lines, uniform finished-product inspection instructions, and a one-month peak-season lead time. Nevertheless, the absence of a valid contract with affiliated subcontractors is a clear production-management deficiency.

Customization capabilityThe supplier explicitly supports customization from samples, designs, full customization, minor customization, and flexible customization, and also provides ODM services. This indicates a broad and clearly stated customization scope.

Product Q&A

Q:Who are we?

We are based in Guizhou, China, start from 2016,sellto Domestic Market(70.00%),Africa(10.00%),North America(.00%),Southeast Asia(5. 00%),SouthAmerica(3.00%),Eastern Asia(3.00%),Western Europe(2. 00 %),0ceanila(1.00%),South Asia(1.00%). There are total about 51-100 people in our office

Q:how can we guarantee quality?

Always a pre-production sample before mass production;Always final Inspection before shipment:

Q:what can you buy from us?

Disposable Vacuum Blood Collection Tube,mask

Q:why should you buy from us not from other suppliers?

Word leading equipment,High quality raw materials and additives, Multiple product types; 10 years exeperience broad cooperation scope.

Q:what services can we provide?

Accepted Delivery Terms: FOB,EXW, Express Delivery; Accepted Payment Currency: USD,EUR,CNY: Accepted Payment Type: T/T,L/C,Wester Union