ISO 13485 Certified Custom Silicone Medical Mask for Devices

Name: ISO 13485 Certified Custom Silicone Medical Mask for Devices
Brand: Shenzhen Kingod Silicone Products Co., Ltd
SKU: 2301301105

Guangdong, ChinaShenzhen Kingod Silicone Products Co., Ltd

US$0.93-1.00

500 Pieces

Sample price:US$100.00/piece.Request sample

Product profile

Customization

Available

Material

LSR

Application

Medical

Certification

ISO, FDA, RoHS

Mask Type

Custom Dust Mask

Core Material

Medical Silicone

Filter Compatibility

Pm2.5 Filters

Seal Design

Full Face Seal

Valve Option

Optional Exhalation Valve

Sterilization Method

Eo Sterilizable

Production Standard

ISO13485/ISO9001

LSR Overmolding

Yes

LSR Bonding

Yes

Transport Package

Box

Specification

Custom LSR Parts

Trademark

Customized Logo

Origin

China

Key features

Soft, skin-friendly medical silicone with a high-elasticity cushion for a quick, one-handed seal on both adults and children. Prevents air leaks and ensures effective ventilation.

Highly transparent for clear visibility. Allows easy observation of the patient's lips and any vomit for timely response.

Autoclavable to meet infection control standards. Resists deformation and aging, reducing long-term replacement costs.

Company profile

High Repeat Buyers ChoiceYears of Export ExperienceExperienced TeamManagement Certification

Shenzhen Kingod Silicone Products Co., Ltd

Guangdong, 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: 16 Years CertifiedNearest Port: Shenzhen PortAverage Response Time: ≤1.97h

AI-Powered supplier vetting

SummaryThe supplier presents itself as a professional technical manufacturing supplier with engineering support, flexible production capacity, LSR injection molding, compression molding, and full customization from development through mass production. It reports FDA- and LFGB-compliant materials and ISO quality management practices, plus documented procedures for corrective actions, customer complaints, and finished-product inspection. R&D evidence includes 3D design, ODM, OEM, new-product development, and multiple customization modes. Manufacturing-related evidence includes valid contracts with associated subcontractors and in-stock capability. However, the supplier reports no SDK, overseas warehouse, overseas showroom, overseas agents or branches, or offline trade-show participation. It also lacks a factory environmental impact assessment report. Financial information is limited to references to records for 2022–2024, without substantive performance values, so financial credibility cannot be determined.

Supplier typeThe supplier is described as a professional technical supplier offering engineering support, product development, LSR injection molding, compression molding, mass production, ODM, and OEM services. These statements support classification as a technical manufacturing supplier rather than only a trading or distribution company.

CertificationsThe supplier states that products use FDA- and LFGB-compliant materials and that production follows ISO quality management systems; it also reports quality assurance in quality-control processes. The evidence describes compliance and management practices, but does not identify specific certificate numbers, issuing bodies, or validity periods.

After-Sales capabilityThe supplier has clear procedures and followed records for corrective and preventive actions and customer complaints, indicating a documented service-response process. It also supports FOB, CIF, CFR, and EXW quotations, but reports no overseas warehouse, overseas showroom, agents, or branches, limiting local overseas service infrastructure.

R&D capabilityThe supplier reports engineering support, 3D software design, customization from samples and designs, new-product development within the past year, and ODM services. It explicitly reports no available SDK, but the available evidence still supports product-development and design capability.

Production capacityThe supplier reports flexible production capacity, LSR injection molding, compression molding, high-precision manufacturing, mass production, standardized finished-product inspection, valid manufacturing contracts with associated subcontractors, and in-stock capability. These statements provide explicit evidence of a broad manufacturing and fulfillment capability.

Customization capabilityThe supplier offers mold development, material selection, structural optimization, mass production, customization from samples, customization from designs, full and flexible customization, and minor customization. This is explicit evidence of end-to-end customization capability.

Product Q&A

Q:Does the silicone material have any unpleasant odor?

Medical-grade silicone is odorless by nature. The product undergoes thorough off-gassing treatment before leaving the factory, so it has almost no smell when opened. For the rare individual with a sensitive sense of smell, simply placing it in a well-ventilated area for a short time will dissipate any trace odor (without affecting performance). Low-quality PVC or ordinary rubber often have a pungent smell - this product has no such issue.

Q:Can the material cause allergic reactions?

This product is made of medical-grade silicone, which offers good biocompatibility and low allergenicity, making it safe for the vast majority of users. Those with known silicone allergies should use with caution or consult a physician.