Factory-Held Certifications — EU, North America & Beyond

Nitrile Glove Certifications & Quality Assurance

ISO 9001:2015 quality management, CE marking, EN 455, ASTM D6319, and FDA 510(k) clearance — the full documentation stack your buyers need, already in place. Certification documents available on request.

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ISO 9001:2015
Certified
5
Market-Access Certifications
AQL 1.5
100% Outgoing Inspection
Since 2007
Third-Party Audit Supported
Documentation Stack

The Certification Stack: What We Hold and What It Covers

We've been exporting nitrile gloves since 2007. The certifications below aren't recent additions — they're the baseline we built the business on, because without them, your buyers in European hospitals, North American healthcare distribution, and regulated industrial procurement simply can't purchase from you.

ISO 9001:2015
Global

Quality management system covering the entire manufacturing operation.

Market Relevance

Required by most institutional buyers as a baseline supplier qualification worldwide.

CE Marking
European Union

EU regulatory framework covering medical and examination gloves for the EU market.

Market Relevance

Mandatory for medical device market access in the European Union.

EN 455
EU Medical

European standard for medical gloves for single use — examination and surgical glove grades.

Market Relevance

EU medical procurement — hospitals, dental networks, clinical distributors.

ASTM D6319
North America

Standard specification for nitrile examination gloves covering tensile strength, elongation, and AQL requirements.

Market Relevance

North American healthcare and industrial safety distribution.

US Market
FDA 510(k)
United States

US Food and Drug Administration clearance for medical examination gloves.

Market Relevance

Required for hospital group and healthcare distributor procurement in the US market.

Every certification listed here is held at the factory level and covers our nitrile glove production. Certification documents — declarations of conformity, test reports, and clearance references — are available on request. We don't ask you to take our word for it.

A note on scope: EN 455 and FDA 510(k) cover our examination glove grades. If you're sourcing industrial or food-contact grades specifically, ask us which certifications apply to that SKU — the answer depends on the exact product, and we'd rather give you the accurate documentation than a blanket claim.

Import Process Guidance

What Each Certification Actually Means for Your Import Process

Listing certifications is easy. What matters to your compliance team is what each one requires and what it unlocks in your target market.

CE Marking + EN 455

EU Medical Market Entry Requirement

CE marking and EN 455 compliance documentation for EU medical glove market

CE marking on a medical glove means the product has been assessed against the EU Medical Device Regulation (MDR 2017/745) requirements. For examination gloves, that assessment is built on EN 455, a four-part standard:

1
EN 455-1 — Freedom from holes
Leak test at AQL 1.5
2
EN 455-2 — Physical properties
Tensile strength, elongation at break, thickness dimensions
3
EN 455-3 — Biological evaluation
Biocompatibility, residual powder levels, protein content. For nitrile: accelerator residue testing applies.
4
EN 455-4 — Shelf life determination
Stability testing under defined storage conditions

For EU distributors: EN 455 compliance is the procurement gate for hospital groups, dental chains, and public health tenders. Without it, your product doesn't get onto the approved supplier list regardless of price. Our CE declaration of conformity is available for your compliance file.

FDA 510(k) + ASTM D6319

North American Healthcare Distribution

FDA 510(k) clearance and ASTM D6319 compliance for North American nitrile glove distribution

FDA 510(k) clearance means our examination gloves have been reviewed by the US Food and Drug Administration as substantially equivalent to a predicate device. For your US buyers — hospital GPOs, healthcare distributors, dental supply companies — this is the document that allows the product to be sold as a medical examination glove in the US market.

ASTM D6319 — The Underlying Performance Standard

ASTM D6319 defines minimum tensile strength, elongation, and AQL requirements for nitrile examination gloves. Our gloves are tested to this standard as part of the 510(k) submission and ongoing production QC.

Medical Device Path

FDA 510(k) + ASTM D6319 — required for hospital GPOs and healthcare distributors selling as a medical examination glove.

Industrial Safety Path

ASTM D6319 compliance alone is often sufficient for industrial safety distributors who don't require medical device classification. Test data available either way.

ISO 9001:2015

The quality system behind every shipment

ISO 9001:2015 certification covers our entire quality management system — from supplier qualification and incoming material inspection through production process control, outgoing inspection, and corrective action procedures. It's renewed annually through third-party audit.

For your procurement process, ISO 9001 means two things practically: our QC procedures are documented and auditable (you can request our quality manual), and our corrective action system is structured to address non-conformances systematically rather than on an ad-hoc basis. When something goes wrong — and in manufacturing, something occasionally does — there's a documented process for identifying root cause and preventing recurrence, not just a promise to do better.

ISO 9001:2015 quality management system audit and documentation process
Documented & Auditable

QC procedures and quality manual available on request for your procurement file.

Annual Third-Party Audit

Certification renewed annually. Structured corrective action system for root cause identification and recurrence prevention.

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Manufacturing Integrity

The Quality Control Process: From Raw Material to Loaded Container

Certifications tell you we've passed an audit. The QC process is what actually keeps your containers clean. Here's how it runs.

01

Incoming Material Inspection

Every batch of nitrile compound, chemical additives, and packaging materials is sampled and tested before it enters production. We check compound viscosity, pH, and chemical composition against our internal specification. Material that doesn't meet spec is rejected — it doesn't go to the line on the assumption that it'll probably be fine.

We mix our own nitrile compound in-house rather than buying pre-mixed from a third-party supplier. This gives us direct control over the formulation entering each production run. Most AQL variance problems in nitrile glove manufacturing trace back to batch-to-batch inconsistency in purchased compound — we removed that variable in the early years and it's one of the main reasons our outgoing AQL results are stable across the year, not just on the first shipment.

02

In-Process Inspection

Each of our 8 automated dipping lines runs with QC sampling every two hours per shift. The checks cover:

  • Dimensional inspection: Thickness measured at palm, finger, and cuff positions. We hold a 0.08–0.15mm tolerance across the run — not just on the sample set submitted for certification.
  • Visual inspection: Surface defects, color consistency, cuff roll uniformity.
  • Online pinhole detection: Every glove on every line passes through an electrical leak test before stripping. Failures are pulled automatically at the line — they don't reach counting and packing.

If a line drifts outside tolerance, it stops. We don't run out-of-spec product and sort it at the end of the shift. The cost of stopping a line for 20 minutes is lower than the cost of a rejected container at your destination port.

Tightest Standard
03

Outgoing Inspection — AQL 1.5 on 100% of Lots

Every finished production lot is inspected to AQL 1.5 before palletization. AQL 1.5 is a tighter standard than the AQL 2.5 that many factories use as their default outgoing inspection level — at AQL 1.5, the acceptable defect rate is lower, which means fewer non-conforming units reach your warehouse and fewer complaints reach your downstream customers.

The inspection covers dimensional conformance, visual defects, packaging integrity, and carton labeling accuracy. Inspection records are maintained per lot and are available as part of the pre-shipment documentation package.

04

Pre-Shipment & Third-Party Verification

Before container loading, we conduct a final pre-shipment inspection against the purchase order specifications. If your procurement process requires third-party verification, we support SGS and Bureau Veritas pre-shipment inspections — we coordinate directly with the inspection agency and provide access to the production lot and documentation.

This is routine for our European and North American buyers; we've done it enough times that it doesn't add friction to the shipment timeline.

In-House Compound Mixing

Why In-House Compound Control Matters for Your AQL Consistency

Most AQL variance problems in nitrile glove manufacturing trace back to batch-to-batch inconsistency in purchased compound. By mixing our own nitrile compound in-house, we removed that variable entirely. The result: outgoing AQL results that are stable across the year — not just on the first shipment you receive.

8
Automated Dipping Lines
AQL 1.5
Outgoing Inspection Standard
2hr
In-Process QC Sampling Interval
100%
Lots Inspected Before Palletization
Export Markets

Compliance Coverage by Export Market

Our certification stack was built around the markets we actually ship to. Here's how it maps.

European Union

CE + EN 455
Key Compliance Requirement

CE marking + EN 455 for medical examination gloves; MDR 2017/745 framework

Our Coverage

CE + EN 455 held; declaration of conformity available

United States

FDA 510(k)
Key Compliance Requirement

FDA 510(k) for medical examination gloves; ASTM D6319 for performance

Our Coverage

FDA 510(k) clearance + ASTM D6319 test data

Middle East

CE + ISO 9001
Key Compliance Requirement

Often requires CE or equivalent; some markets accept ISO 9001 + test reports for industrial grades

Our Coverage

CE + ISO 9001 covers most procurement requirements

Southeast Asia

ISO 9001 + CE
Key Compliance Requirement

Varies by country; ISO 9001 + CE widely accepted for medical and industrial procurement

Our Coverage

ISO 9001 + CE covers the majority of market requirements

Australia

CE + ISO 9001
Key Compliance Requirement

TGA registration for medical devices; CE + ISO 9001 accepted for industrial grades

Our Coverage

CE + ISO 9001 for industrial; contact us for TGA-specific requirements

Other Markets

For markets not listed, or for specific procurement requirements — government tenders, hospital group approved supplier lists, retail chain compliance programs — contact us with the specific documentation your buyer requires. We'll confirm what we can provide.

Ask About Your Market
Market Key Compliance Requirement Our Coverage
European Union CE marking + EN 455 for medical examination gloves; MDR 2017/745 framework CE + EN 455 held; declaration of conformity available
United States FDA 510(k) for medical examination gloves; ASTM D6319 for performance FDA 510(k) clearance + ASTM D6319 test data
Middle East Often requires CE or equivalent; some markets accept ISO 9001 + test reports for industrial grades CE + ISO 9001 covers most procurement requirements
Southeast Asia Varies by country; ISO 9001 + CE widely accepted for medical and industrial procurement ISO 9001 + CE covers the majority of market requirements
Australia TGA registration for medical devices; CE + ISO 9001 accepted for industrial grades CE + ISO 9001 for industrial; contact us for TGA-specific requirements
European Compliance

Accelerator-Free Compliance: The EN 455 Requirement That's Reshaping European Medical Procurement

This section is worth reading if you're supplying European hospital groups, dental networks, or any healthcare buyer with a Type IV allergy policy.

The Accelerator Problem

Standard nitrile gloves use thiuram and carbamate accelerators in the vulcanization process. These accelerators are the primary documented cause of Type IV (delayed) allergic reactions in healthcare workers. European hospital procurement has been moving toward accelerator-free specifications for several years — some hospital groups now require it as a condition of approved supplier status, not just as a preference.

Our Production Approach

We run accelerator-free nitrile compound on a dedicated production line, using a sulfur-donor cure system that eliminates thiuram and carbamate residues. The resulting glove passes EN 455 parts 1–4 and carries no detectable accelerator residue on standard testing protocols.

Cure System
Sulfur-donor — no thiuram, no carbamate residues
Certification
EN 455 parts 1–4 compliant
Production Line
Dedicated line — same facility, no separate supplier
Documentation
Test data confirming accelerator residue levels available
For Distributors Building a European Healthcare SKU Mix

Accelerator-free is a specification that opens procurement doors that standard nitrile can't enter. Because we produce it from the same facility on a dedicated line, it doesn't require a separate supplier relationship. We've seen consistent demand growth in this segment since 2019. If you're not already carrying an accelerator-free SKU for your European accounts, it's worth the conversation.

Dedicated accelerator-free nitrile glove production line

Type IV Allergy: Why European Buyers Are Mandating Accelerator-Free

1
Thiuram & Carbamate Accelerators
Used in standard vulcanization; primary documented trigger for Type IV delayed hypersensitivity reactions in healthcare workers.
2
Hospital Group Procurement Shift
Many European hospital groups now require accelerator-free as a condition of approved supplier status — not a preference, a gate.
3
EN 455 Parts 1–4
Our accelerator-free glove passes all four parts. Compliance file test data available on request.
Supplier Qualification

Third-Party Audits and Buyer-Initiated Inspections

Our ISO 9001:2015 certification is renewed through annual third-party audit. Beyond the certification audit cycle, we support buyer-initiated factory audits and pre-shipment inspections as a standard part of the sourcing process — not as a special accommodation.

SGS Factory Audit

Social compliance and quality system audit. Supported as part of standard supplier qualification — not a special request.

Bureau Veritas (BV) Inspection

Pre-shipment and process audit. We coordinate logistics directly with BV inspectors on your behalf.

Buyer Quality Team Visits

On-site visits from your QC or procurement team accommodated with advance scheduling. No special approval process required.

Audit Reports & Supplier Approval Process

We don't publish specific audit scores or report numbers publicly — those are provided directly to the requesting buyer as part of the qualification process. If your supplier approval process requires a factory audit report, contact us and we'll coordinate the logistics.

Audit reports are shared directly with the requesting buyer — not published on this site.
ISO 9001:2015
Annual third-party renewal audit
SGS & Bureau Veritas
Internationally recognized inspection bodies
Buyer-Initiated Visits
On-site access with advance scheduling
Request Audit Coordination
Buyer Resources

Frequently Asked Questions: Nitrile Glove Certifications

Which certifications do your gloves carry for the US market?

Our nitrile examination gloves hold FDA 510(k) clearance and are tested to ASTM D6319. For US healthcare distribution — hospital groups, dental supply, clinical procurement — the 510(k) is the document your buyers need. For industrial safety distribution where medical device classification isn't required, ASTM D6319 test data is typically sufficient. We can provide both.

What is the difference between EN 455 and ASTM D6319 for nitrile examination gloves?

EN 455 is the European standard for medical gloves for single use — it covers physical properties, freedom from holes, biological evaluation, and shelf life. ASTM D6319 is the North American performance standard for nitrile examination gloves, covering tensile strength, elongation, and AQL requirements. They're parallel standards for their respective markets, not interchangeable. A glove can hold both, which ours does — EN 455 for EU procurement and ASTM D6319 for North American procurement.

Can you provide test reports and certification documents for our compliance file?

Yes. We provide CE declarations of conformity, FDA 510(k) reference documentation, EN 455 and ASTM D6319 test reports, and our ISO 9001:2015 certificate as part of the standard documentation package. For new buyers, these are included with the sample shipment. For existing buyers, updated documents are provided at each certification renewal.

What AQL standard do you use for outgoing inspection?

AQL 1.5 on 100% of finished production lots. This is tighter than the AQL 2.5 default used by many factories. At AQL 1.5, the sampling plan accepts a lower defect rate — practically, this means fewer non-conforming units in your shipment and fewer downstream complaints from your customers.

Do your certifications cover accelerator-free nitrile gloves as well as standard grades?

Yes. Our accelerator-free gloves are produced on a dedicated line and tested to EN 455 parts 1–4. The CE declaration and EN 455 test reports cover the accelerator-free grade specifically — we don't apply standard-grade documentation to a different product. If you're sourcing accelerator-free for European healthcare accounts, we can provide the grade-specific documentation.

Can you support a third-party factory audit as part of our supplier qualification process?

Yes. We support SGS and Bureau Veritas audits and accommodate buyer quality team visits. Contact us with your audit requirements and timeline — we'll coordinate directly.

Supplier Qualification

Request Certification Documentation

If you're at the supplier qualification stage, the fastest path forward is to request our documentation package and a sample shipment together. The sample gives your QC team something to test; the documentation gives your compliance team something to file.

Tell us your target market and the specific certifications your buyers require — we'll confirm which documents apply and send the package with the samples. For buyers whose procurement process includes a factory audit, we can schedule that in parallel.

Request Documentation & Samples OEM/ODM Capabilities

Certification documents are available upon request. Specific certification validity periods and audit report details are provided directly to qualified buyers as part of the supplier qualification process.