EN 455 & FDA 510(k) Certified Manufacturer

Powder Free
Medical Nitrile Gloves

Examination-grade powder free medical nitrile gloves with full compliance documentation — CE, EN 455, and FDA 510(k) clearance ready to ship with every lot.

Manufactured on 8 automated dipping lines with 100% AQL 1.5 outgoing inspection and online pinhole detection. The certification paperwork your healthcare buyers require is already in order — you're not waiting on us to pull it together at inquiry time.

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EN 455 FDA 510(k) Cleared AQL 1.5 18+ Years Manufacturing 1-Container MOQ

Powder free medical nitrile gloves — examination grade, EN 455 and FDA 510(k) certified

Outgoing Inspection

100%

AQL 1.5 every lot

Medical Grade Defined

What Makes This a Medical-Grade SKU — and Why That Distinction Matters for Your Channel

Powder free medical nitrile gloves aren't just examination gloves without powder. The "medical grade" designation carries a specific regulatory meaning: the glove has been tested and cleared as a medical device, not just a general-purpose barrier product. In practice, that means EN 455 compliance for European healthcare procurement and FDA 510(k) clearance for US hospital and clinical supply channels.

Without those certifications, your downstream buyers — hospital groups, dental networks, clinical labs — can't put the product on their approved vendor list regardless of how good the glove actually is.

We hold both. Every lot of our powder free medical nitrile gloves ships with a CE declaration of conformity referencing EN 455 Parts 1–4, an FDA 510(k) clearance reference number, and our internal AQL test report for that specific production lot.

The documentation package is assembled per lot, not pulled from a generic file — so when your buyer's procurement team asks for the test data on the specific container they received, you have it.

This is the SKU for healthcare distribution, dental supply, clinical laboratory supply, and any channel where your buyer's compliance team will ask for paperwork before the product goes on the shelf.

Request Documentation Samples and a Quote

EN 455

Parts 1–4 CE declaration per lot

FDA 510(k)

Clearance reference number with every shipment

Per-Lot AQL Report

Test data tied to the specific container received

Exact Parameters

Technical Specifications

These are the exact parameters for this SKU. If your project requires a specification outside these ranges, contact us — our compounding lab handles custom formulation from the same facility.

Standard Examination-Weight SKU

Material 100% nitrile rubber (acrylonitrile-butadiene)

Grade Medical examination

Thickness

Palm 0.08–0.10 mm (typical: 0.09 mm)

Finger 0.10–0.12 mm

Cuff 0.06–0.08 mm

Dimensions & Sizing

Length 240 mm (standard)

Sizes XS, S, M, L, XL

Color Blue (standard); white available

Surface & Finish

Inner surface Chlorinated — powder-free donning, no cornstarch residue

Surface finish Smooth palm; textured fingertip available

Mechanical Properties

Tensile strength (pre-aging) ≥14 MPa

Elongation at break (pre-aging) ≥500%

Quality Control

AQL standard 1.5 (100% of outgoing lots)

Pinhole detection Online electrical leak test, every glove

Options

Accelerator-free option Available on request — sulfur-donor cure system

Specifications are for standard examination-weight SKU. Contact us for exact data sheets on specific lot orders.

Key Performance Metrics

Tensile Strength ≥14 MPa

Elongation at Break ≥500%

AQL Outgoing Inspection 100%

Accelerator-Free Option

Sulfur-donor cure system available on request — critical for European hospital tenders requiring Type IV allergy documentation.

Ask about accelerator-free spec

Custom Formulation

Specification outside these ranges? Our compounding lab handles custom formulation from the same facility.

Discuss custom spec

Nitrile glove thickness cross-section — palm, finger, and cuff measurement zones

Get a Quote for This SKU

Ready to source? Request a quote with lot-specific documentation included.

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Compliance Documentation

Compliance Documentation That Ships With Every Container

The certification question comes up at every stage of healthcare channel distribution — at your buyer's procurement approval, at customs, and again when the end-user facility runs its annual vendor audit. We've structured our documentation to answer all three.

CE Declaration of Conformity

References EN 455 Parts 1 (freedom from holes), 2 (physical properties), 3 (biological evaluation), and 4 (shelf life determination).

FDA 510(k) Clearance Reference

The clearance number that satisfies US healthcare channel procurement requirements, included with every shipment.

ISO 9001:2015 Certificate

Quality management system certification required by most institutional procurement programs globally.

Internal AQL Test Report

Lot-specific report covering dimensional measurements, tensile strength, elongation at break, and AQL results tied to the lot number on your cartons.

ASTM D6319 Compliance

Nitrile examination glove standard for North American distribution, documented and included with every production lot.

Third-Party Pre-Shipment Inspection

We coordinate with SGS or Bureau Veritas. You get an independent inspection report tied to the specific container before it ships — lot number on the carton label traces back to the production record and test data.

Buyers have told us lot-traceable third-party inspection was what moved us from shortlist to approved vendor. It's not a special service — it's how we handle every container.

Need the full documentation package for your procurement process?

We provide the complete cert bundle — CE, FDA, ISO, AQL lot report, and ASTM — ready for your vendor approval submission.

Request Documentation Package

Manufacturing Consistency

How We Hold Spec Across a Full Year of Orders

The hardest thing to find in a powder free medical nitrile gloves supplier isn't a good first sample. It's a factory that ships the eighth container to the same spec as the first. This is where most sourcing relationships break down — not at the sample stage, but six months in when something quietly changes.

The Root Cause Most Factories Miss

Most nitrile glove factories buy pre-mixed compound from a third-party chemical supplier. When that supplier changes their batch formulation — which happens without notice — the factory's glove thickness shifts. The factory doesn't catch it because they're not measuring compound viscosity; they're measuring finished gloves at AQL 2.5, which allows enough variance through that the problem only surfaces at your destination port or in your customer's hands.

We built our own compounding lab in the early years specifically because we kept seeing this failure mode in the market. The sample you approved is representative of what ships in container 8. For medical distribution, where your downstream buyers are running their own incoming inspection and your reputation is on the line with every delivery, that consistency is the commercial value — not just a manufacturing detail.

Learn About Our Manufacturing Process

In-house nitrile compound mixing lab with viscosity and pH monitoring

In-House Compounding

Formulation team mixes nitrile compound in-house, monitoring viscosity, pH, and acrylonitrile content on every batch before it goes to the line.

Bath Temperature Control

Bath temperature on each of our 8 dipping lines is held to ±1°C. Dipping speed is controlled by automated conveyor — not operator judgment.

Dimensional Checks Every 2 Hours

Checks run every two hours per line. Any drift outside the 0.08–0.10mm palm thickness tolerance triggers a line stop, not a sorting operation.

Container 8 = Container 1

The result of in-house compounding and automated line controls: the spec you approved on your first order is what ships on your eighth.

Distribution Channels

Market Segments Where This SKU Generates Repeatable Volume

Powder free medical nitrile gloves move through several distinct procurement channels, each with its own order pattern and compliance requirements. Here's how we see the commercial landscape for buyers building distribution in these segments.

Hospital & Clinical

Hospital and Clinical Supply

Hospital group procurement runs on annual tender cycles. Once you're on the approved vendor list with the right certification documentation, the volume is predictable and the reorder frequency is high. EN 455 and FDA 510(k) are the entry requirements; AQL 1.5 documentation is increasingly written into tender specifications as a baseline, not a premium. This segment rewards suppliers who can provide lot-traceable documentation quickly — procurement teams don't have time to chase paperwork.

Dental

Dental Network Distribution

Dental practices consume examination gloves at high per-chair volume, and dental supply distributors typically run consolidated SKU programs across large practice networks. Blue powder-free medical nitrile is the dominant specification. Accelerator-free is worth adding to your dental SKU mix — Type IV allergy sensitivity is more prevalent among dental professionals than the general population, and some dental networks are already specifying accelerator-free as a standard requirement. We've seen this shift accelerate in the European dental market since 2021 — worth building into your product line before it becomes a tender requirement rather than after.

Lab & Diagnostics

Clinical Laboratory and Diagnostics

Labs run through examination gloves at volume, and their procurement is often centralized at the facility or network level. The key specification concern here is chemical resistance and barrier integrity — our 0.08–0.10mm medical grade provides adequate barrier for standard lab handling. For labs working with stronger solvents or cytotoxic compounds, the industrial-grade SKU at heavier gauge is the better fit; we can supply both grades and help you spec the right one for your buyer's application.

Medical supply distributors and private label programs

Distributors & OEM

Medical Supply Distributors and Importers

If you're building a private-label medical glove line or adding a house-brand examination glove to your catalog, this SKU is the foundation. One 40HQ container (approximately 2,000 boxes) is the MOQ for standard SKUs with your artwork. The full technical file for your regulatory submission — CE technical documentation, FDA 510(k) reference, test reports — is available as part of the OEM package.

Ready to discuss your target market and get a quote?

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Accelerator-Free Production

Accelerator-Free Option: The Specification That Opens European Hospital Tenders

Standard nitrile vulcanization uses thiuram and carbamate chemical accelerators. These compounds are the primary trigger for Type IV (delayed) allergic reactions in healthcare workers — a growing compliance issue that has moved from a niche concern to a mainstream procurement specification in European hospital and dental procurement over the past several years.

Dedicated Line. No Cross-Contamination.

We run accelerator-free compound on a dedicated line, using a sulfur-donor cure system instead of the standard thiuram/carbamate process. The resulting glove carries no detectable accelerator residue and passes EN 455 for all barrier performance parameters. It's not a reformulation of the standard SKU — it's a separate cure system running on a dedicated line, which is why we can guarantee no cross-contamination with accelerator-containing compound.

EN 455

Full barrier performance compliance

1 × 40HQ

Same MOQ as standard nitrile

Zero

Detectable accelerator residue

Tender access, not a niche add-on. For distributors supplying European hospital groups, dental networks, or any buyer whose end users include sensitized healthcare workers, accelerator-free is increasingly a specification that determines whether you're in the tender or out of it. The price premium over standard nitrile is modest; the market access it provides is not. If you're building a European healthcare distribution business and you're not offering accelerator-free, you're losing tenders to suppliers who are.

Ask About Accelerator-Free Availability and Pricing

Dedicated accelerator-free nitrile glove production line

Why Accelerator-Free Is Becoming a Standard Specification

Type IV allergy sensitivity is more prevalent among dental professionals than the general population — dental networks are already specifying accelerator-free as a standard requirement.
The shift has accelerated in the European dental market since 2021. Building it into your product line before it becomes a tender requirement is the right commercial move.
It's a standard production variant we run regularly — not a custom project. MOQ is one 40HQ container, same as standard.

Explore Related SKUs

Buyer Guidance

Sourcing FAQs: Powder Free Medical Nitrile Gloves

What certifications are required to sell nitrile examination gloves into hospital procurement in Europe vs. the US?

For European hospital and clinical procurement, EN 455 (Parts 1–4) is the baseline medical device standard, and CE marking is required for market entry. Many hospital group tenders additionally specify ISO 9001:2015 for the manufacturer's quality management system.

For US healthcare channel sales — hospital supply, clinical distribution, dental supply — FDA 510(k) clearance is required; ASTM D6319 is the product performance standard.

We hold all of these: CE, EN 455, FDA 510(k), ASTM D6319, and ISO 9001:2015. If you're distributing into both markets, the same SKU covers both — you just need the right documentation package for each channel, which we provide per lot.

What is the difference between AQL 1.5 and AQL 2.5 for medical gloves, and does it matter for my buyers?

AQL (Acceptable Quality Level) defines the maximum acceptable defect rate in a production lot. AQL 1.5 allows a maximum of 1.5 defective units per 100 — AQL 2.5 allows 2.5.

For medical gloves, where barrier integrity is the core performance requirement, the difference is meaningful: a lot that passes AQL 2.5 outgoing inspection can still contain up to 2.5% defective gloves. Hospital procurement teams and medical device distributors increasingly specify AQL 1.5 as a minimum requirement.

We run 100% AQL 1.5 outgoing inspection on every lot — not sampling-based, every lot — combined with online electrical pinhole detection on every glove. Your incoming inspection results and your customers' complaints reflect that standard.

When should I specify accelerator-free nitrile gloves for my buyers?

If your buyers supply European hospital groups, dental networks, or any healthcare setting where end users have documented latex or chemical sensitivities, accelerator-free is worth specifying.

Type IV allergic reactions to thiuram and carbamate accelerators are more common among healthcare workers than the general population — European hospital procurement is increasingly writing accelerator-free as a baseline specification rather than a premium option.

If you're unsure whether your target market requires it, ask us — we can tell you what our existing customers in your region are specifying.

What is the minimum order quantity for powder free medical nitrile gloves?

One 40HQ container — approximately 2,000 boxes (200,000 gloves for standard examination weight). This applies to standard SKUs in existing formulations and colors.

Sample orders are supported before container commitment; samples ship within 5–7 business days with the full certification documentation package for the specific lot.

How do I confirm that the gloves I receive match the approved sample specification?

Every production lot ships with an internal test report covering AQL results, dimensional measurements (palm, finger, and cuff thickness), tensile strength, and elongation at break — all tied to the specific lot number on your cartons.

For third-party verification, we coordinate pre-shipment inspection with SGS or Bureau Veritas; you receive an independent inspection report before the container ships. The lot number on the carton label traces back to the full production record and test data.

Samples Ship in 5–7 Business Days

Ready to Source
Powder Free Medical Nitrile Gloves?

If you know your spec — grade, color, certification requirements, target market — send us the details and we'll turn around a quote with lead time and container loading data within one business day.

If you're evaluating this SKU against others in our line, the disposable nitrile gloves category page covers the full product range including industrial-grade and blue medical-grade variants — useful if you're building a multi-SKU sourcing program.

Most new buyers start with a sample order before committing to a container. Samples ship within 5–7 business days and include the full certification documentation package: CE declaration of conformity, FDA 510(k) reference, and our internal test report for the specific lot.

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Contact Our Sourcing Team

sales@glovemfg.com

Phone

+86 155 3755 6387

Powder Free Medical Nitrile Gloves