ISO 9001:2015 · CE · EN 455 · ASTM D6319 · FDA 510(k)

Powder Free
Nitrile Gloves

Factory-direct, examination grade. Chlorinated inner surface, 0.08–0.10mm palm thickness — manufactured on 8 automated dipping lines with in-house compound control.

Every lot ships with full certification documentation for North American and European markets. AQL 1.5 outgoing inspection, online pinhole detection on every glove, every line.

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Powder free nitrile gloves — examination grade, factory direct

18+

Years Nitrile-Only

Dipping Lines

AQL 1.5

Every Outgoing Lot

100%

Pinhole Detection

Product Overview

What This Product Is and Where It Sits in the Line

Powder free nitrile gloves are the volume product in our line — the SKU that moves in the largest quantities across the widest range of channels. Medical distribution, dental supply, general industrial safety, food-contact applications, private-label programs: this is the glove that anchors most buyers' SKU mix because it covers the broadest range of end-use requirements without requiring a specialized formulation or a premium price point.

The "powder free" designation means the inner surface is chlorinated rather than dusted with cornstarch powder. Chlorination tightens the surface layer of the nitrile, reducing tackiness so the glove dons cleanly without powder residue. For your downstream customers — whether they're clinicians, food handlers, or assembly workers — no powder means no contamination risk and no respiratory irritation from airborne starch.

For you as a distributor or importer, it means the product meets the baseline specification for virtually every institutional procurement program in North America and Europe. Powdered examination gloves have been banned from US healthcare settings since 2017 (FDA final rule); powder-free is not a premium option, it's the market standard.

Chlorinated inner surface of powder free nitrile glove enabling clean donning

Examination Weight Thickness Range

0.08–0.10mm

Palm

0.10–0.12mm

Finger

0.06–0.08mm

Cuff

This thickness range covers the vast majority of medical, dental, and light industrial applications. For heavier gauge chemical handling or extended-wear industrial tasks, see our powder free industrial nitrile gloves — a separate SKU with a different thickness spec and certification documentation.

View the full disposable nitrile gloves range to compare all SKUs by application, thickness, and certification scope.

Technical Data

Exact Specifications for This SKU

Request Quote with Target Spec

These are the parameters your procurement team needs to fill a comparison sheet. Where industry-standard values apply, they're noted as such — contact us for the specific test report for any production lot.

Full Parameter Table

Parameter	Specification
Material	100% nitrile rubber (acrylonitrile-butadiene)
Powder status	Powder-free (chlorinated inner surface)
Thickness — palm	0.08–0.10mm (typical examination grade)
Thickness — finger	0.10–0.12mm
Thickness — cuff	0.06–0.08mm
Length	240mm (standard)
Sizes	XS, S, M, L, XL
Surface finish	Smooth (standard); textured fingertip available
Color	Blue (standard); black, white, purple, green available
Tensile strength (pre-aging)	≥14 MPa (EN 455-2 / ASTM D6319)
Elongation at break (pre-aging)	≥500%
AQL standard	1.5 (outgoing inspection, 100% of lots)
Pinhole detection	Online electrical leak test, every glove
Accelerator-free option	Available on request (dedicated line, sulfur-donor cure)
Certifications	ISO 9001:2015, CE, EN 455, ASTM D6319, FDA 510(k)
Packing	100 pcs/box, 10 boxes/carton
Container loading (40HQ)	~2,000 cartons (~200,000 boxes)

Specifications shown are standard values for this product type. Actual lot measurements are provided in the per-lot test report shipped with every container. Contact us for detailed product data sheets.

Powder free nitrile gloves — 100 pcs box, 10 boxes per carton packing

Certification Coverage

ISO 9001:2015 Quality Mgmt

CE Mark EU Market

EN 455 Medical Gloves

ASTM D6319 US Standard

FDA 510(k) US Healthcare

Container Quick-Ref

Per box 100 pcs

Per carton 10 boxes / 1,000 pcs

40HQ container ~2,000 cartons

Total per 40HQ ~200,000 boxes

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Process Engineering

How We Hold Thickness Tolerance Across a Full Production Run

Examination-grade gloves run at 0.08–0.10mm palm thickness. That's a 0.02mm working window. Hold it across one shift on one line and it's manageable. Hold it across 8 lines, multiple shifts, and a 20-million-piece container order — that's a process engineering problem, not a quality inspection problem.

The factories that fail AQL at destination aren't failing because their inspectors missed something. They're failing because their compound viscosity drifted between batches and nobody caught it until the gloves were already packed.

We built our own compounding lab specifically to own this variable. Our formulation team mixes nitrile compound in-house, checking viscosity, pH, and acrylonitrile content on every batch before it goes to the line.

The result is that the glove you pull from carton 1,800 of a 2,000-carton container measures within tolerance of the glove from carton 1. That's the consistency problem that experienced buyers have already been burned by before they find us.

In-House Compounding Lab

Viscosity, pH, and acrylonitrile content checked on every batch before it reaches the line. No compound supplier to switch — we make our own.

Bath Temperature ±1°C Hard Limit

Not a target — a hard control limit on every dipping line. Dipping speed runs on automated conveyor, not operator judgment.

Dimensional Sampling Every 2 Hours

Palm, finger, and cuff thickness measured and logged per line. Any line drifting outside tolerance stops immediately — we don't run out-of-spec product and sort it later.

Sample Approval Is Representative

The sample you approved is representative of what ships in month 8 of your annual contract, not just the first shipment. Plan around us — not monitor us constantly.

"The first two containers were fine, then something changed." — We hear this regularly from buyers who come to us after a compound supplier switch their previous factory didn't disclose. We don't have a compound supplier to switch.

Documentation & Compliance

Certification Coverage for Your Key Markets

Every powder free nitrile glove we ship carries the documentation your buyers need to sell into regulated procurement channels. These aren't certifications we're working toward — they're current, and the documentation ships with every lot.

ISO 9001:2015

Quality Management System

Global institutional procurement. The baseline quality system certification required by most international B2B buyers.

CE Marking

EU Product Conformity

Required for European market entry. Confirms the product meets EU safety, health, and environmental protection requirements.

EN 455 (Parts 1–4)

Medical Gloves for Single Use

European healthcare and hospital tenders. Covers barrier performance, physical properties, biological evaluation, and shelf life — all four parts.

ASTM D6319

Nitrile Examination Gloves

North American healthcare and industrial channels. The standard equivalent to EN 455 for the US and Canadian markets.

US Required

FDA 510(k)

Medical Device Clearance

Required for US hospital and clinical supply channels. Without it, your US healthcare buyers cannot put the product on their approved vendor list.

Accelerator-Free Variant

Supplying European hospital groups with tender specs that include accelerator-free requirements? This variant runs on a dedicated line and ships with EN 455 compliance plus accelerator residue test results.

Ask us about this variant specifically when requesting a quote.

Lot-Specific Test Documentation

If your buyer requires specific test data — AQL results for a production lot, tensile strength measurements, pinhole test records — we provide the documentation for the specific lot you're ordering, not a generic certificate dated two years ago.

Lot number on carton label traces back to production record and test data

AQL results, tensile strength, and pinhole test records available per lot

Certification documentation ships with every lot

Learn More About Our Manufacturing & Certifications

Market Segments Where This SKU Generates Repeatable Volume

Powder free nitrile gloves at examination weight sell into several distinct procurement channels. Each has different volume patterns, different documentation requirements, and different margin dynamics.

Medical

Medical and Dental Distribution

Hospital group tenders, dental supply chains, outpatient clinic procurement programs. These buyers specify EN 455 or ASTM D6319 compliance as a baseline requirement; FDA 510(k) is required for US healthcare channel entry. The documentation is already in order for this SKU.

Order patterns in this segment tend to be annual contract-based with quarterly releases — once you're on an approved vendor list, the reorder is largely automatic. Margin in this channel is thinner than industrial, but volume is high and reorder frequency is predictable.

Industrial

Industrial Safety and MRO Distribution

General assembly, light manufacturing, electronics handling, janitorial and facilities maintenance. Examination-weight powder free nitrile is the standard spec for these applications — thick enough for barrier protection, thin enough for dexterity.

Black is the dominant color in industrial channels (hides grease, signals industrial-grade positioning); blue works for food-adjacent industrial applications. MRO distributors typically carry 2–3 SKUs in this category and reorder on consumption-based triggers, making it a steady replenishment segment.

Food Service

Food Processing and Food Service Supply

Institutional food service contractors, food processing facility supply programs, restaurant supply distributors. Blue and white colorways for contamination visibility. Food-contact compliance documentation (FDA 21 CFR, EU 10/2011) is available for this SKU on request.

Food service is a high-volume, price-sensitive channel — the margin per box is lower, but the order frequency is high and the switching cost for buyers is low, so supplier reliability matters more than price differentiation.

Private Label

Private-Label and House Brand Programs

Distributors building their own brand in a specific market. One 40HQ container (~2,000 boxes) is the MOQ for standard powder free nitrile in our existing formulations and colors with your artwork. The compounding lab handles any formulation adjustments; the production lines run your spec; the QC team inspects to your AQL requirement. We don't subcontract any part of this.

This segment has grown steadily for us — buyers who've been burned by inconsistent quality from other factories often come to us specifically to build a house brand they can stand behind.

OEM and Private-Label: What's Actually Customizable

For this specific SKU, here's what's available without a custom formulation project. The category page covers the full OEM scope.

Standard Customization

Container MOQ — No development lead time

Box and carton artwork under your brand name
Color selection: blue (standard), black, white, purple, green
Size mix within a single container (XS through XL)
Textured fingertip surface finish instead of smooth

Custom Formulation

Container MOQ — Sample approval stage required

Accelerator-free compound for sensitization-sensitive markets
Custom color matched to a Pantone reference
Specific elongation-at-break targets for specialized applications
Higher acrylonitrile content for improved chemical resistance

What Cannot Be Customized on This SKU

Thickness spec outside the 0.08–0.10mm examination range — that moves you to the industrial grade SKU

Length outside 240mm standard — non-standard lengths require tooling changes and a separate MOQ discussion

MOQ for Standard Private-Label

One 40HQ Container — ~2,000 Boxes

No separate tooling fee for packaging artwork — included in OEM project setup. Custom formulation projects start at the same container MOQ for the production run, with a sample approval stage before full production.

Explore OEM/ODM Options

Container Loading and Landed Cost Inputs

Standard examination-weight powder free nitrile gloves pack at 100 pieces per box, 10 boxes per carton. A properly loaded 40HQ container carries approximately 2,000 cartons — 200,000 boxes, 20 million pieces. Carton dimensions are standardized so mixed-color or mixed-size loads don't create dead space.

For buyers consolidating multiple SKUs into a single container — powder free standard alongside blue or medical grade — we can provide a loading plan with exact carton counts per SKU before you confirm the order. This matters for landed cost calculations: knowing the exact box count per container lets you work backward to a per-box landed cost before you commit.

Lead time for standard SKUs: 25–35 days from order confirmation. For repeat orders on established SKUs, we maintain a rolling production schedule that allows us to confirm ship dates at order time rather than after production planning.

Pack Configuration

100 pcs / box

10 boxes per carton

40HQ Capacity

2,000 cartons

200,000 boxes · 20M pieces

Standard Lead Time

25–35 days

From order confirmation

Inspection

SGS / Bureau Veritas

Pre-shipment coordination standard

Documentation & Compliance

Country-of-origin documentation

Carton labeling to Amazon FBA or distributor DC requirements

Full export documentation

Buyer Guidance

Sourcing FAQs: Powder Free Nitrile Gloves

What's the difference between powder free and accelerator-free nitrile gloves — and when does it matter?

Powder free means no cornstarch or other powder on the inner surface — the glove dons cleanly via a chlorinated inner surface treatment. Accelerator-free means the vulcanization process uses no thiuram or carbamate chemical accelerators, which are the primary trigger for Type IV allergic reactions in healthcare workers.

A glove can be powder free but still contain accelerator residue. If you're supplying standard medical, dental, or industrial channels, powder free is the correct specification. If you're supplying European hospital groups or dental networks where tender specifications are starting to require accelerator-free compliance, you need the dedicated accelerator-free variant — ask us specifically about that SKU.

How do I verify that production lots match the approved sample?

Every lot ships with an internal test report covering AQL results, dimensional measurements (palm, finger, and cuff thickness), tensile strength, and elongation at break for that specific lot. The lot number on the carton label traces back to the production record.

If your procurement process requires third-party verification, we coordinate pre-shipment inspection with SGS or Bureau Veritas — you get an independent inspection report tied to the specific container before it ships.

What is the minimum order for powder free nitrile gloves wholesale?

One 40HQ container — approximately 2,000 boxes (200,000 gloves at examination weight) for standard SKUs in existing formulations and colors. Sample orders ship within 5–7 business days with full certification documentation before you commit to a container.

Can I mix sizes and colors in one container?

Yes. Size mix (XS through XL) and color mix (blue, black, white, purple, green) within a single container are standard. We provide a loading plan with exact carton counts per SKU before order confirmation so your landed cost calculation is accurate before you commit.

Does powder free nitrile meet food-contact compliance requirements?

Yes. Our standard powder free nitrile formulation meets food-contact requirements under FDA 21 CFR and EU Regulation 10/2011. We can provide the compliance documentation on request. Blue and white are the standard colorways for food-contact applications — both run without MOQ premium.

What certifications does this product carry for the US healthcare channel?

FDA 510(k) clearance and ASTM D6319 compliance for the US market. EN 455 (Parts 1–4) and CE marking for European healthcare. ISO 9001:2015 covers the quality management system globally. All certifications are current; documentation is available for review before you place an order.

Factory-Direct Sourcing

Get a Quote for Powder Free Nitrile Gloves

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

New to sourcing from us? Samples ship within 5–7 business days with the full certification documentation package for the specific lot. Most buyers test the product with their own customers before committing to a container — that's the right way to do it.

Request a Quote Contact Us

Or email us directly: sales@glovemfg.com

Quote turnaround: 1 business day

Includes lead time, container loading data, and per-unit pricing at your target volume.

Samples: 5–7 business days

Full certification documentation package included with every sample shipment — tied to the specific production lot.

MOQ: 1 × 40HQ container

~2,000 boxes / 200,000 gloves. Size and color mix within a single container at no premium.

OEM & ODM Services