EN 455 · ASTM D6319 · FDA 510(k) · AQL 1.5

Powdered Medical
Nitrile Gloves

Corn-starch powdered medical nitrile gloves — EN 455 and ASTM D6319 compliant, built for markets where powdered examination gloves remain in active clinical procurement.

Same nitrile compound, same AQL 1.5 inspection standard, same 8-line automated production — with a controlled corn-starch dusting step for donning ease in high-volume clinical environments.

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Product Overview

What This Product Is — and Where It Belongs in Your Catalog

Powdered medical nitrile gloves are a specific procurement SKU, not a legacy holdover you should quietly phase out. Corn-starch powder applied to the inner surface reduces donning friction in high-throughput clinical settings — emergency departments, outpatient clinics, and nursing wards where staff are gloving and degloving dozens of times per shift. In markets where this specification remains compliant and actively procured, it's a real line item with real demand.

The regulatory picture is the first thing to get straight before you stock this SKU. The FDA banned powdered surgeon's gloves and powdered patient examination gloves for the US market effective January 2017 — if your distribution is primarily North American, this product is not for you. The EU has similarly restricted powdered gloves under the Medical Device Regulation for most clinical applications.

Where powdered medical nitrile gloves remain in active procurement is Southeast Asia — Indonesia, the Philippines, Vietnam, Thailand — and parts of the Middle East, where certain hospital systems and government health procurement bodies still specify powdered examination gloves for donning ease and cost reasons. If those are your markets, this SKU belongs in your catalog. If they're not, the powder-free examination gloves are the right starting point.

We produce this variant on the same automated dipping lines as our powder-free range, with a corn-starch dusting step added after stripping. The nitrile compound is identical — same formulation, same thickness profile, same cure process. The powder application is controlled by weight per glove to stay within EN 455 Part 1 requirements for powder quantity. EN 455-1 sets a maximum of 2 mg absorbable powder per glove — we run below that threshold and verify by lot.

Powdered medical nitrile gloves being donned in a clinical setting

≤2mg

Powder per glove

EN 455-1 compliant

AQL 1.5

Inspection standard

100% outgoing lots

18+

Years manufacturing

Nitrile specialist

Automated lines

Same as powder-free

Active procurement markets

Southeast Asia (Indonesia, Philippines, Vietnam, Thailand) and parts of the Middle East — where hospital systems and government health procurement bodies still specify powdered examination gloves.

Product Data

Technical Specifications

Specifications shown are industry-standard values for this product type. Actual specifications may vary by production lot. Contact us for detailed product data sheets and lot-specific test reports.

Full Specification Table

Parameter Specification

Material 100% synthetic nitrile butadiene rubber (NBR)

Powder type Corn starch (absorbable, USP-grade)

Powder quantity ≤2 mg per glove (EN 455-1 compliant)

Thickness — palm 0.08–0.10 mm (typical examination weight)

Thickness — finger 0.10–0.13 mm

Thickness tolerance ±0.01 mm across production run

Tensile strength ≥14 MPa (EN 455-2 / ASTM D6319)

Elongation at break ≥500% (pre-aging)

AQL inspection 1.5 (100% of outgoing lots)

Pinhole detection Online electrical leak test, every glove

Sizes XS, S, M, L, XL

Colors Blue (standard); white available on OEM runs

Packaging 100 pcs/box, 10 boxes/carton (standard)

Sterility Non-sterile

Certifications

ISO 9001:2015

Quality management system

CE Mark

European conformity

EN 455

Medical gloves for single use

ASTM D6319

Nitrile examination gloves

FDA 510(k)

US market clearance

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Get lot-specific test reports, detailed product data sheets, or arrange a sample order for evaluation.

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Manufacturing Process

The Corn-Starch Dusting Step: How We Control It

Most quality variables in a powdered glove are identical to any nitrile examination glove. The one variable unique to this SKU is powder application — and it's where powdered gloves most commonly create downstream problems.

Tumble-Dusting Chamber

After stripping from the former, gloves pass through a tumble-dusting chamber where corn-starch powder is applied by controlled airflow. The chamber is calibrated to deliver a consistent powder weight per glove.

Powder Quantity Verification

We check powder quantity by sampling finished gloves from each lot and weighing them against undusted control samples. The target is uniform coverage at the minimum effective quantity — enough to reduce donning friction, not so much that powder accumulates visibly in packaging or exceeds the EN 455-1 limit.

USP-Grade Corn Starch Only

The corn starch we use is USP-grade absorbable powder — the same specification required for surgical glove dusting historically, and the grade that meets EN 455 requirements for absorbable powder in medical gloves. We don't use talc or non-absorbable powder.

This matters for markets where customs or health authority inspectors check powder type — USP corn starch is the only absorbable powder specification that clears EN 455 and most Southeast Asian import requirements without additional documentation.

Corn-starch tumble-dusting chamber for powdered nitrile glove production

Integrity Check Sequence

Every glove passes the electrical leak test on the production line

Gloves proceed to the dusting chamber only after passing integrity check

The dusting process itself introduces no variable into the barrier integrity result

Pinhole detection runs the same way as on our powder-free lines. The powder step happens after the integrity check.

Distribution Strategy

Market Fit: Where This SKU Generates Margin

Powdered examination gloves are a shrinking global market, but "shrinking globally" and "unavailable in your target segment" are different things. The buyers who source this SKU profitably are the ones who understand exactly which markets still specify it and why.

Southeast Asian hospital and clinic procurement for powdered examination gloves

Southeast Asia Hospital

Southeast Asian Hospital & Clinic Procurement

Government hospital systems in Indonesia, the Philippines, and Vietnam have historically specified powdered examination gloves in public health tenders, partly for cost reasons and partly because donning ease in high-volume ward environments is a real operational concern.

These tenders run on annual cycles with large volume commitments — a distributor with an established relationship in this segment moves significant carton volume on predictable reorder schedules.

Required Certification

EN 455 compliance for import clearance

Middle East GCC

Middle Eastern Healthcare Distribution

Certain GCC and broader Middle Eastern hospital procurement systems still carry powdered examination gloves as a line item alongside powder-free. The split varies by country and by institution type — private hospitals in the UAE have largely moved to powder-free, while some government procurement in other GCC markets still includes powdered variants.

If you're building a Middle Eastern medical distribution catalog, carrying both specifications gives you coverage across the full tender landscape without leaving line items on the table.

Emerging market private clinic chains sourcing cost-effective powdered nitrile examination gloves

Emerging Markets Private Clinics

Emerging Market Private Clinics

In markets where healthcare infrastructure is expanding rapidly and cost-per-procedure is a primary procurement driver, powdered gloves remain competitive on price and donning efficiency.

A distributor supplying private clinic chains in these markets can position powdered nitrile as the cost-effective examination glove for high-volume, lower-acuity settings — with powder-free variants available for procedure rooms where the clinical environment warrants it.

Inventory Strategy Note

If you're adding this SKU to an existing powder-free catalog, we'd suggest starting with a single container to test sell-through in your specific market before committing to larger stock positions. The regulatory trajectory in most markets is toward powder-free, and the right inventory posture is responsive rather than speculative.

Compliance & Import

Regulatory Position: What You Need to Know Before You Import

This is the section that determines whether this product belongs in your sourcing plan.

United States

FDA banned powdered patient examination gloves and powdered surgeon's gloves effective January 18, 2017 (21 CFR 880.6250 and 878.4460).

This product cannot be legally sold as a medical examination glove in the US market.

Our FDA 510(k) clearance covers our powder-free examination glove line; it does not extend to this powdered variant for US distribution.

European Union

Under EU MDR 2017/745, powdered gloves intended to be used as medical devices are subject to restrictions.

CE marking and EN 455 compliance are maintained for this product, but EU distribution requires verification of applicable national regulations in your target country.

We recommend confirming current import status with your regulatory counsel before placing an order for EU distribution.

Southeast Asia & Middle East

EN 455 compliance is the primary import requirement in most of these markets, and this product holds that certification.

ASTM D6319 compliance covers North American-aligned procurement specifications that some Southeast Asian buyers reference.

We've shipped this SKU into Southeast Asian and Middle Eastern markets routinely — the paperwork requirements are familiar to us.

Documentation Package Available

We can provide the full certification documentation package — CE declaration of conformity, EN 455 test reports, lot-specific AQL records — to support your import clearance process. Country-specific import requirements vary; send us the destination country and we'll tell you what documentation we can provide.

Confirm Documentation

Specification Guidance

Powdered vs. Powder-Free: Helping Your Buyers Choose

If you're distributing into markets where both specifications are in active procurement, your downstream buyers will ask you to explain the difference. Here's the commercial framing.

Clinical ward staff donning powdered nitrile gloves in high-throughput environment

Powdered This SKU

Faster Donning in High-Throughput Environments

Powdered gloves offer faster donning — relevant in high-throughput clinical environments where staff glove and deglove repeatedly throughout a shift. The corn-starch powder reduces the friction of pulling a nitrile glove over a slightly damp hand, which matters in ward environments without consistent access to glove-donning stations or talc dispensers.

Best Fit

High-volume ward and clinic environments
Markets where powdered gloves remain legal
Southeast Asian and Middle Eastern clinical procurement

Powder-free nitrile gloves used in procedure room and surgical setting

Powder-Free Alternate SKU

Zero Contamination Risk for Procedure & Surgical Settings

Powder-free gloves eliminate the risk of powder contamination in the clinical environment — relevant in procedure rooms, surgical settings, and any environment where airborne particulate is a concern. They're also the specification required in markets with regulatory restrictions on powdered gloves.

Best Fit

Procedure rooms and surgical settings
Environments where airborne particulate is a concern
Markets with regulatory restrictions (US, EU)

Barrier Performance: Equivalent Across Both Variants

The barrier performance — tensile strength, elongation, pinhole integrity — is equivalent between the two variants. The nitrile compound and dipping process are identical; the only difference is the post-stripping dusting step.

Identical

Nitrile Compound

Identical

Dipping Process

1 Step

Difference: Post-Strip Dusting

SKU Positioning for Distributors

For a distributor, the practical implication is SKU positioning: powdered for high-volume ward and clinic environments in compliant markets, powder-free for procedure rooms, surgical settings, and any market with regulatory restrictions. Carrying both gives you coverage across the full clinical procurement landscape in markets where both remain legal.

View Powder-Free Line

Packaging, Container Loading, and Export Logistics

Standard pack configuration: 100 gloves per box, 10 boxes per carton. A properly loaded 40HQ container carries approximately 2,000 cartons — 2 million gloves. Carton dimensions are the same as our powder-free examination glove line, so container loading efficiency is identical.

Pack Configuration

100 gloves per box · 10 boxes per carton · ~2,000 cartons per 40HQ container (2 million gloves).

Carton Labeling

Configurable to your distributor DC requirements or private-label specifications. Country-of-origin documentation, packing lists, and commercial invoices are standard.

Pre-Shipment Inspection

We coordinate with SGS and Bureau Veritas for markets requiring pre-shipment inspection — routine on Southeast Asian and Middle Eastern orders.

Lead Time

25–35 days from order confirmation. Powdered production runs on a scheduled basis rather than continuously — lead time confirmation at order time depends on line scheduling.

Sample Orders

Ship within 5–7 business days and include the full certification documentation package for the specific production lot.

CE declaration of conformity
EN 455 test reports
Internal AQL records

Cartons of powdered medical nitrile gloves staged for 40HQ container loading

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Customization Options

MOQ for standard SKUs: one 40HQ container (approximately 2,000 boxes). MOQ for OEM/private-label runs: one 40HQ container. Custom formulation requests — contact us to discuss feasibility and development lead time.

Option	Available	Notes
Color	Yes	Blue (standard), white on OEM runs. Custom color available on OEM runs ≥1 × 40HQ.
Private-label packaging	Yes	Box and carton design under your brand name.
Custom box count	On request	Non-standard pack configurations available for OEM.
Accelerator-free formulation	Not standard	Not standard for this SKU. Available on request — contact us to discuss.
Size range	Full range	XS, S, M, L, XL — all sizes available in standard production.

Custom formulation or OEM run?

Frequently Asked Questions

Are powdered medical nitrile gloves legal to import and sell in my market?

It depends on the destination. The US FDA banned powdered patient examination gloves effective January 2017 — they cannot be sold as medical gloves in the US. The EU has restrictions under MDR 2017/745. Southeast Asian markets (Indonesia, Philippines, Vietnam, Thailand) and most Middle Eastern markets generally permit powdered examination gloves under EN 455 compliance. If you're uncertain about your specific destination, send us the country and we'll confirm what documentation we can provide to support import clearance.

What type of powder is used, and does it meet EN 455 requirements?

USP-grade corn starch — absorbable powder, the specification required under EN 455-1 for powdered medical gloves. Powder quantity is controlled to ≤2 mg per glove per EN 455-1 limits, verified by lot sampling. We do not use talc or non-absorbable powder.

Does the powder affect barrier integrity or AQL results?

No. Pinhole detection runs before the dusting step — every glove passes the electrical leak test before powder is applied. The dusting process does not introduce a barrier integrity variable. Outgoing AQL 1.5 inspection covers the finished powdered gloves, so the AQL standard is the same as our powder-free line.

What certifications does this product carry?

ISO 9001:2015, CE marking, EN 455 (Parts 1–4), and ASTM D6319. FDA 510(k) clearance is held for our powder-free examination glove line; the FDA ban on powdered examination gloves means 510(k) is not the relevant certification for this SKU in US distribution. Full documentation — CE declaration of conformity, EN 455 test reports, lot-specific AQL records — ships with every order.

What is the minimum order quantity?

One 40HQ container for standard SKUs — approximately 2,000 boxes (200,000 gloves) at standard pack configuration. Sample orders are available before full container commitment; samples ship within 5–7 business days with the full certification documentation package.

Can I order both powdered and powder-free SKUs in the same container?

Yes. Mixed-SKU container orders are supported for buyers who want to carry both specifications for their market. Contact us with your target SKU mix and volumes and we'll confirm loading configuration and lead time.

Factory-Direct Supply

Source Powdered Medical Nitrile Gloves Direct from the Manufacturer

glovemfg ships to Southeast Asia, the Middle East, and other markets where powdered medical examination gloves remain in active procurement. If you're evaluating this SKU for your distribution catalog, the fastest path is a sample order — samples ship within 5–7 business days with the full EN 455 and ASTM D6319 documentation package for the specific production lot.

If you already know your volume and target market, send us the details and we'll turn around a quote with confirmed lead time and a clear statement of what certification documentation we can provide for your destination.

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sales@glovemfg.com

Phone

+86 155 3755 6387

Powdered Medical Nitrile Gloves