Custom Medical Mask Manufacturing Your Brand, Your Spec, Our Certified Production
From private-label 3-ply surgical masks to modified N95 configurations, we handle the development, production, and compliance documentation. MOQ from 50,000 pieces on standard SKUs.
What OEM and ODM Actually Mean Here — and Which One You Need
We get this question often enough that it's worth addressing directly. OEM and ODM describe two different starting points for a custom project, and the right model depends on what you're bringing to the table.
OEM — Your Brand on Our Validated Design
OEM means you're applying your brand to a product we already manufacture. You provide the artwork, the packaging spec, and the labeling requirements. We run your order on our existing production lines, print your brand on the packaging, and ship.
The product itself — the mask construction, the filtration spec, the materials — is our validated design. This is the faster path to market and the lower-risk option for buyers who are entering a new product category or building a private-label healthcare line without an in-house product development team.
Artwork approval to bulk shipment: 15–25 days
ODM — Custom Development to Your Spec
ODM means you need something we don't currently run as a standard SKU. A different ear-loop configuration. A modified filtration target. A 4-ply construction with a specific inner layer material. A tie-on surgical mask for a market that requires it.
In these cases, we go through a development process — adjusting our meltblown parameters, sourcing modified components, running trial production, and validating the new configuration against the target performance spec before we commit to full production. We have the in-house capability to do this because we control the filtration layer ourselves. Most mask factories can't modify filtration performance without changing fabric suppliers; we can change the fiber diameter and basis weight on our own meltblown line.
Spec confirmation to first production batch: 35–60 days (depending on modification complexity)
Both models are available across our full product range:
The Capability That Makes Custom Filtration Specs Possible
Most of what we can offer in ODM customization comes back to one thing: we produce our own meltblown nonwoven fabric. This is the middle layer in a medical mask — the one that does the actual filtration work. Every other layer is structural or comfort-related. The meltblown layer is what determines whether a mask achieves ≥95% BFE, ≥98% BFE, or a specific PFE target.
When you buy from a factory that sources meltblown externally, their filtration spec is whatever their fabric supplier ships that week. They can test it and reject non-conforming rolls, but they can't change the spec — they can only accept or reject what arrives. We set the fiber diameter, the basis weight, and the electrostatic charge level on our own production equipment. If you need a mask that hits a specific BFE target for a hospital procurement tender, or a configuration that meets both EN 14683 Type IIR and ASTM F2100 Level 2 simultaneously, we can engineer the filtration layer to that target rather than hoping a standard roll gets us there.
This matters commercially because it gives your product a defensible spec. A private-label mask that hits ≥98% BFE with documented in-house test data and third-party verification is a different product from a commodity 3-ply that claims the same number based on a fabric supplier's certificate. Your downstream buyers — hospital procurement teams, government tender evaluators, institutional distributors — increasingly know the difference. In-house meltblown production is the mechanism that makes a verified, repeatable filtration spec possible across your entire order volume.
Our in-house QC lab runs BFE, PFE, and Delta-P testing on every production batch, including custom configurations. The test data from your order is yours — it travels with the shipment and supports your import documentation, your customer's compliance review, and any downstream audit your buyer conducts.
External Sourcing vs. In-House Meltblown
BFE Testing
Bacterial Filtration Efficiency tested per batch on in-house equipment. Data included with shipment.
PFE Testing
Particulate Filtration Efficiency verified for custom configurations targeting specific performance thresholds.
Delta-P (Breathability)
Differential pressure measured to ensure filtration performance doesn't compromise wearer comfort.
Customization Scope: What We Can and Can't Do
Here's the honest version of our customization capability. We'd rather tell you the boundaries upfront than have you discover them after sample approval.
Mask Construction and Configuration
| Dimension | Customizable Range |
|---|---|
| Ply count | 3-ply, 4-ply |
| Ear-loop style | Ear-loop, head-tie, behind-head elastic |
| Nose wire | Single wire, double wire, aluminum or steel |
| Mask shape | Flat-fold, duckbill, cup-shaped |
| Size | Adult standard, adult large, pediatric |
| Color (outer layer) | White, blue, black, custom colors |
Filtration Performance
We can target specific BFE and PFE levels by adjusting meltblown parameters. Standard configurations:
EN 14683 Type II / ASTM F2100 Level 1
EN 14683 Type IIR / ASTM F2100 Level 2
If your market or tender requires a specific performance threshold, tell us the standard and the target — we'll confirm whether we can hit it before you commit to sampling.
Packaging and Labeling
This is where most private-label projects live. We handle:
Individual Polybag
Individual polybag packaging with your brand artwork
Box-of-50 Retail
Retail cartons with full-color printing
Box-of-10 Clinical
Hospital packaging for clinical/institutional use
Bulk Poly-Bag
Institutional supply bulk packaging
Master Carton Labeling
Your SKU, lot number, and barcode format
Language Variants
English, French, Arabic, Spanish, and German labeling produced for different markets
Artwork files should be provided in AI, EPS, or high-resolution PDF format. We'll send a packaging proof for approval before production runs.
What We Don't Customize
We don't modify the cleanroom production environment or the core ultrasonic welding process — those are fixed infrastructure.
We don't produce non-medical-grade masks under our ISO 13485 certification. If you need industrial dust masks or non-certified PPE, that's a different product category.
We don't do custom ear-loop materials below 100,000 pieces — the material procurement and line setup cost doesn't make sense for either of us at lower volumes.
From First Inquiry to Bulk Shipment: The Collaboration Process
We've run enough OEM and ODM projects to know that the process itself is where most problems originate — unclear specs, sample approval delays, undocumented changes between sample and production. Here's how we structure it.
Requirements Discussion
Day 1–3Send us your target market, the performance standard you need to meet, your packaging concept, and your volume expectations. We'll come back with a product recommendation, a preliminary spec sheet, and a price range.
If you have an existing product you're trying to match or improve on, send us a sample — we'll test it in our lab and tell you exactly where it lands against the standard.
Quotation and Spec Confirmation
Day 3–7Once we align on the product configuration, we issue a formal quotation with the confirmed spec, MOQ, unit price, lead time, and payment terms. This document becomes the reference for everything that follows.
Changes after spec confirmation are possible but add time — we'd rather spend an extra day getting the spec right than discover a mismatch at sample approval.
Sample Production and Approval
Day 7–20 (OEM) / Day 14–35 (ODM)We produce a sample run — typically 100–200 pieces — and ship to you for evaluation. The sample package includes the physical masks, the in-house test report (BFE, PFE, Delta-P), and the packaging proof if packaging is part of the project.
You test, review, and either approve or provide feedback. We allow two rounds of sample revision at no charge; additional rounds are billed at cost.
Practical note: Buyers who test the samples against their own market's standard before approving — rather than relying solely on our test report — catch fit issues and performance edge cases that we might not anticipate. We encourage it.
Production Agreement and Deposit
Upon ApprovalSample approval triggers the production agreement. Standard payment terms are 30% deposit on order confirmation, 70% balance before shipment.
We can discuss letter of credit arrangements for orders above 5 million pieces. Once the deposit clears, your order enters the production schedule.
Mass Production and In-Process QC
Lead Time Varies by VolumeYour order runs on our dedicated production lines. In-process QC checkpoints run at defined intervals — weld integrity, ear-loop attachment force, nose wire placement, mask dimensions.
Any out-of-spec production stops the line. We send production progress updates at the midpoint and when production completes.
Outgoing Inspection and Pre-Shipment Testing
Final QCBefore packaging, a statistically sampled batch from your production run goes through full performance testing: BFE, PFE, Delta-P, plus visual inspection and packaging integrity check.
The test report from this stage is the document that travels with your shipment. If you require a third-party pre-shipment inspection (SGS, BV, or equivalent), we coordinate access and provide the necessary documentation.
Packaging, Documentation, and Shipment
DeliveryWe pack to your carton configuration, prepare the full export documentation package — certificate of conformity, test reports, packing list, commercial invoice — and arrange shipment via your nominated freight forwarder or ours.
EU-Bound Shipments
We prepare the CE technical file documentation your importer of record will need.
US-Bound Shipments
We include the FDA registration documentation and any required labeling compliance statements.
MOQ, Lead Times, and the Numbers That Affect Your Planning
Standard OEM
Existing SKU, custom packaging
50,000 pieces
15–25 days
from sample approval
Custom Color or Configuration
Minor modification
100,000 pieces
20–30 days
from sample approval
ODM
New configuration, modified filtration spec
200,000 pieces
35–60 days
from spec confirmation
Trial / Sample Order
Evaluation quantities
200–500 pieces
7–14 days
Lead Time Assumptions
Lead times assume raw material availability and standard production scheduling. During peak demand periods — which in this industry tend to cluster around Q4 and around any significant respiratory disease event — lead times extend.
We'll tell you the current schedule when you inquire, not after you've placed the order.
Capacity at Scale
Annual capacity is 120 million pieces across 6 production lines.
A 500,000-piece OEM order is a routine run for us.
A 5-million-piece order requires scheduling coordination but doesn't require us to add capacity — it fits within our normal operating parameters.
Intellectual Property and Brand Protection
Private-label programs involve your brand assets, your packaging design, and sometimes your product specifications. Here's how we handle that.
NDA Coverage
We sign NDAs before any project discussion that involves proprietary specifications or unreleased brand assets.
The NDA covers our production team, our QC team, and any subcontractors involved in your project. We don't share client specifications, artwork files, or product configurations with other buyers.
Segregated File Access
Each client's files are stored separately and access is restricted to the team working on that project. No cross-contamination of brand assets, packaging designs, or product configurations between buyer accounts.
Design Ownership
For ODM projects where you've contributed to the product design — a specific configuration, a modified construction, a proprietary material combination — we document the design ownership in the production agreement. Your design is yours. We don't run it for other buyers without your written authorization.
Mold & Tooling Ownership
Mold ownership for custom packaging components — custom-shaped boxes, branded dispensers, specialty packaging — follows the same principle: if you paid for the tooling, the tooling is yours.
We hold it in our facility for your reorders, but we don't use it for other clients.
A Note on Competitors
We've had buyers ask whether we sell to their competitors. The honest answer: we don't track who your competitors are, and we do sell to multiple buyers in the same product category.
What we don't do is share your specific brand assets, your packaging design, or your proprietary product configuration with anyone else.
Markets Where Your Custom Mask Program Can Land
The commercial case for a private-label medical mask program depends on which market you're selling into and what that market's procurement structure looks like. Here's where our existing OEM buyers are building volume:
Hospital and Clinical Supply Chains
Institutional procurement in North America and Europe increasingly requires documented supplier qualification: ISO 13485, FDA clearance or CE marking, and third-party test reports. Our certification stack covers all of these.
Buyers building a private-label program for hospital distribution can use our regulatory documentation as the foundation for their own supplier qualification submissions.
Government and Emergency Stockpile Tenders
Tender specifications in the Middle East, Southeast Asia, and Africa typically require CE or equivalent certification, specific BFE performance thresholds, and country-of-origin documentation.
We've supplied into tender programs in multiple markets and can prepare the documentation package your tender submission requires.
Pharmacy and Retail Healthcare
Retail-ready packaging, shelf-appeal design, and consumer-facing labeling are all within our OEM scope. Pharmacy chains and healthcare retailers in Europe and North America are a repeatable, margin-positive segment.
Distributors who can offer a differentiated private-label product rather than a commodity SKU build stronger retail relationships and better margins.
Industrial and Workplace Safety Distribution
High-volume, lower-margin, but predictable reorder cycles. Distributors supplying construction, manufacturing, and logistics sectors with certified respiratory protection can build a defensible position.
A private-label product that carries documented performance specs is harder to commoditize than an unbranded equivalent.
Common Questions About OEM/ODM Collaboration
Practical answers to the questions procurement teams ask most often when evaluating a private-label mask manufacturing partner.
What is the minimum order for a private-label project?
What is the minimum order for a private-label project?
50,000 pieces for standard SKUs with custom packaging. If you need a modified product configuration, the minimum rises to 100,000–200,000 pieces depending on the scope of the modification.
We can do sample orders of 200–500 pieces before you commit to full production.
How long does it take from first contact to first shipment?
How long does it take from first contact to first shipment?
For a straightforward OEM project — existing product, custom packaging — plan for 3–5 weeks from initial inquiry to shipment. That includes spec confirmation, sample production and approval, and production lead time.
ODM projects with product modifications run 6–10 weeks.
These are realistic ranges, not best-case scenarios.
Can you match a competitor's product or an existing product we're currently sourcing?
Can you match a competitor's product or an existing product we're currently sourcing?
Send us a sample. We'll test it in our lab — BFE, PFE, Delta-P — and tell you exactly what spec it's hitting. Then we'll tell you whether we can match it, exceed it, or why a particular configuration isn't feasible on our lines.
We'd rather give you an honest answer at the sample stage than a problem at the production stage.
What certifications will my product carry?
What certifications will my product carry?
Products manufactured under our ISO 13485:2016 quality management system and produced in our CE (EU MDR) and FDA 510(k) registered facility can carry those certifications in your documentation.
The specific certifications that apply to your product depend on the product type and target market — we'll confirm this during the requirements discussion.
Certification documents are available upon request.
Do you accept third-party factory audits?
Do you accept third-party factory audits?
Yes. We support SGS, BV, TUV, and equivalent third-party audits. If your procurement process requires a factory audit before order placement, contact us to schedule.
We've been through multiple audit cycles and the facility is audit-ready.
What file formats do you need for custom packaging artwork?
What file formats do you need for custom packaging artwork?
AI, EPS, or high-resolution PDF (300 dpi minimum). We'll send a dieline template for your packaging format so your designer works to the correct dimensions.
Packaging proofs are reviewed and approved before production runs.
Start Your Custom Mask Program
If you're building a private-label healthcare brand, stocking a distribution program, or fulfilling a tender that requires a documented supplier — send us your requirements. Tell us your target market, the performance standard you need to meet, and your volume expectations. We'll come back with a specific product recommendation and a preliminary quote.
New to Medical Mask Sourcing?
Tell us which market you're selling into and what your downstream buyers require — we'll walk you through the certification and documentation landscape before you commit to anything.
For questions about our quality system and certification documentation, see our Certifications & Compliance page.
Gaomi Eztio Medical Technology Co., Ltd. — Building 3, Zhilan Industrial Park, No. 88 Heng'er Road, Gaomi Economic Development Zone, Gaomi, Weifang, Shandong, 261500, China
Email: [email protected] · WhatsApp: +86 190 0636 0409