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

Black Medical
Nitrile Gloves

Full EN 455 / ASTM D6319 / FDA 510(k) compliance, in the color your dental and aesthetic clinic accounts actually want.

Same powder-free, AQL 1.5 specification as our standard examination line. The black colorant is compounded in-house, so the barrier properties don't change — only the color does.

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EN 455 ASTM D6319 FDA 510(k) 100% AQL 1.5 18+ Years Nitrile Manufacturing

Commercial Case

Why Black Gloves Are a Separate SKU Worth Carrying

Black medical nitrile gloves carry the same technical specification as a standard examination glove — same thickness range, same tensile strength, same AQL standard, same certifications. The commercial case for stocking them separately has nothing to do with performance and everything to do with the market segments that specify black by preference or by practice.

Black nitrile gloves in dental operatory setting

Dental Practices

Black gloves have become a visual standard in dental operatories across North America and Europe. The contrast against teeth and oral tissue is part of the clinical workflow, and the aesthetic signals professionalism to patients in a way that blue or white doesn't. A mid-sized dental distributor serving 400–600 practices moves meaningful black glove volume on monthly reorder cycles. The practices that have switched to black rarely switch back — making this a sticky, recurring segment rather than a one-time order.

Black nitrile gloves used in aesthetic and cosmetic clinic

Aesthetic & Cosmetic Clinics

Dermatology clinics, medical spas, tattoo studios, and permanent makeup practitioners all use black as a visual brand element — it reads as premium and clinical simultaneously. These buyers are less price-sensitive than hospital procurement departments, and their reorder frequency is high. This segment has grown steadily in North American and European distributor accounts — it's worth building into your catalog if you're not already carrying it.

Black nitrile gloves in food processing and industrial contamination-sensitive application

Food Processing & Industrial

Food processing and industrial buyers who need a medical-grade glove for contamination-sensitive applications specify black because it makes contamination visible — a torn glove fragment in a food production line is immediately detectable against a light-colored product. Some of these buyers specifically request FDA 510(k)-cleared gloves because their facility audits require it, even though the application isn't clinical.

The Distributor Implication

Black medical nitrile is not a substitute for blue or white — it's an additive SKU that opens segments your standard examination glove line doesn't reach. The MOQ is the same, the certification stack is the same, and the production process is the same. The margin profile is modestly better than commodity blue because the competitive set is smaller and the buyers who want black are less likely to switch on price alone.

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Product Data

Technical Specifications

Black medical nitrile gloves from glovemfg are produced on the same automated dipping lines as the full examination glove range, with the same in-house nitrile compound and the same QC checkpoints. The black pigment is dispersed into the compound at the mixing stage — it's not a surface coating or a post-production treatment, so it doesn't affect the glove's physical properties or barrier integrity.

Parameter	Specification
Material	100% nitrile butadiene rubber (NBR), powder-free
Color	Black (pigment compounded in-house)
Palm thickness	0.08–0.12mm (typical examination weight)
Finger thickness	0.10–0.14mm
Thickness tolerance	±0.01mm across production run
Tensile strength	≥14 MPa (EN 455-2 / ASTM D6319)
Elongation at break	≥500% (pre-aging)
Surface finish	Textured fingertip (standard); smooth available on OEM runs
Powder status	Powder-free
Accelerator status	Standard thiuram/carbamate cure; accelerator-free available on request
Sizes	XS, S, M, L, XL
Packaging	100 pcs/box, 10 boxes/carton (standard)
Sterility	Non-sterile
Certifications	ISO 9001:2015, CE, EN 455, ASTM D6319, FDA 510(k)
AQL standard	1.5 (100% of outgoing lots)
Pinhole detection	Online electrical leak test, every glove

Specifications shown are standard values for this SKU. Contact us for exact data sheets or to discuss custom specification requirements.

AQL 1.5 — Every Lot

Every outgoing lot is tested to AQL 1.5. Combined with online electrical leak testing on every individual glove, this is the same QC standard applied across our full medical examination range — not a relaxed spec for a color variant.

Accelerator-Free Option

For dental networks or aesthetic clinics in European markets where Type IV allergy documentation is part of the procurement specification, we can produce black gloves in the accelerator-free formulation. Same black color, same EN 455 compliance, no detectable accelerator residue. MOQ is one 40HQ container. The buyers who need it will pay a premium and the competitive set is thin.

Request a Sample or Data Sheet

We can provide physical samples and full technical data sheets for procurement review. Contact us with your target market and volume requirements.

Request a Quote or Sample

Also in Medical Nitrile Gloves

Disposable Medical Nitrile White Nitrile Medical Blue Medical Examination Nitrile Powdered Medical Nitrile Surgical Nitrile Cleanroom Nitrile Laboratory Nitrile

OEM & Private Label

Customization Options

Black medical nitrile gloves from glovemfg can be customized across several dimensions without requiring a new product development cycle.

Packaging

Standard is 100 pcs/box, 10 boxes/carton. Carton labeling configurable to your brand specifications, Amazon FBA requirements, or distributor DC requirements. Private-label box printing available at one 40HQ container MOQ.

Accelerator-Free Formulation

Available for the black SKU. Same black color, EN 455 compliant, no detectable accelerator residue. MOQ one 40HQ container. Relevant for European dental and hospital distribution where Type IV allergy documentation is required.

Thickness Profile

Standard examination weight is 0.08–0.12mm palm. Dental procedure weight at 0.10–0.13mm available — dipping parameters adjusted for your OEM run. Confirm feasibility with us before ordering.

Textured vs. Smooth Fingertip

Standard is textured fingertip for grip. Smooth fingertip available on OEM runs for buyers whose customers prefer it — some aesthetic clinic buyers request smooth for tactile sensitivity during facial procedures.

Custom Color Shade

Standard black is a deep, consistent black. Charcoal or dark grey available via Pantone reference match through the compounding lab. Requires a formulation development phase before production.

What We Don't Customize

Size range — XS–XL is fixed for standard SKUs
Certification scope — EN 455 / ASTM D6319 / FDA 510(k) are the certifications held; no additional market-specific certifications beyond these
Sterility — this SKU is non-sterile; contact us to discuss feasibility for sterile black gloves

Discuss Custom Specifications

Regulatory

Certifications and Compliance for Your Target Markets

The certification stack for black medical nitrile gloves is identical to the standard examination line — the color change doesn't affect regulatory status.

Market Certification Coverage

European Union / EEA

CE marking + EN 455 (Parts 1–4)

Held

United States

FDA 510(k) clearance + ASTM D6319

Held

Canada

Health Canada — references ASTM D6319

Covered via ASTM

Australia / New Zealand

TGA — references EN 455

Covered via EN 455

Middle East (GCC)

SASO / GSO — references EN 455

Covered via EN 455

Southeast Asia

EN 455 widely accepted

Covered via EN 455

Full Documentation Package

CE declaration of conformity, FDA 510(k) reference number, EN 455 test reports, and lot-specific AQL records ship with every order. For sample orders, the complete documentation package goes out with the samples.

Regulated Procurement Environments

For buyers supplying hospital GPOs, government health tenders, or dental chain procurement, documentation is structured to satisfy both ISO 9001 auditors and FDA import reviewers.

Pre-Shipment Third-Party Inspection

If your procurement process requires pre-shipment third-party inspection, we coordinate with SGS and Bureau Veritas — this is routine on our North American and European orders.

Learn About Our Manufacturing & Quality Systems

Logistics

Packaging, Loading, and Logistics

Standard Pack Configuration

100 pcs/box, 10 boxes/carton. Carton dimensions are optimized for 40HQ loading efficiency — no wasted cubic space in a standard load.

40HQ Container Capacity

A properly loaded 40HQ container carries approximately 2,000 cartons — 2 million gloves at standard pack configuration.

Lead Time

25–35 days from order confirmation on standard black medical nitrile SKUs. Repeat orders on established SKUs run on a rolling production schedule — ship dates confirmed at order time, not after production planning.

Configurable Carton Labeling

Your brand name, Amazon FBA barcodes, distributor DC requirements, or our standard glovemfg label. Country-of-origin documentation, packing lists, and commercial invoices are standard on every shipment.

MOQ & Samples

MOQ: one 40HQ container (~2,000 boxes) for standard black examination gloves. Sample orders ship within 5–7 business days with the full certification documentation package.

100 pcs

Per Box

10 boxes

Per Carton

2,000

Cartons / 40HQ

Gloves / 40HQ

Buyer Questions

Frequently Asked Questions

Are black medical nitrile gloves certified to the same standards as blue or white examination gloves?

Yes. The black colorant is compounded into the nitrile formulation at the mixing stage — it doesn't affect the glove's physical properties or barrier integrity. Our black medical nitrile gloves carry the same EN 455, ASTM D6319, and FDA 510(k) certifications as the standard examination line. The same AQL 1.5 outgoing inspection and online pinhole detection apply to every production run.

Does the black pigment affect tensile strength or elongation?

Not in our formulation. We adjusted the compound's cure profile when we developed the black variant to compensate for the pigment's effect on compound viscosity. Tensile strength meets ≥14 MPa (EN 455-2 / ASTM D6319) and elongation at break meets ≥500% pre-aging — the same as the standard examination glove. If you want to verify this against your own incoming inspection, request a sample order and we'll include the lot-specific test report.

Can you produce black medical nitrile gloves in an accelerator-free formulation?

Yes. We run accelerator-free compound on a dedicated line using a sulfur-donor cure system. The black accelerator-free variant passes EN 455 with no detectable accelerator residue. This is the specification for European dental and hospital procurement environments where Type IV allergy documentation is part of the tender. MOQ is one 40HQ container. Contact us to discuss lead time and pricing.

What is the MOQ for black medical nitrile gloves?

One 40HQ container for standard black examination gloves — approximately 2,000 boxes (200,000 gloves) at standard 100 pcs/box pack configuration. Sample orders are available before full container commitment and ship within 5–7 business days with the full certification documentation package.

Why do dental practices and aesthetic clinics prefer black gloves over blue?

The clinical reason is contrast — black provides better visual contrast against teeth, oral tissue, and skin during procedures. The commercial reason is brand presentation: black reads as premium and clinical in a way that commodity blue doesn't, and practices that have made the switch tend to specify it consistently. For your distribution business, this means black glove buyers are less likely to switch suppliers on price alone than buyers of standard blue examination gloves.

How do I know the black color will be consistent across multiple container orders?

We use a single approved pigment supplier and check color against a reference standard on every production run. Batch-to-batch color variation is a known issue with black gloves from factories that don't control their pigment sourcing — it's one of the complaints we hear from buyers who've had problems elsewhere. If color consistency across orders matters for your private-label packaging, request samples from two separate production runs before committing to a full container program.

Factory-Direct Sourcing

Source Black Medical Nitrile Gloves
Direct from the Manufacturer

If you're evaluating black medical nitrile gloves for your distribution line, the fastest path is a sample order. We'll ship samples within 5–7 business days with the full certification documentation package — EN 455 test reports, FDA 510(k) reference, and lot-specific AQL records — so you can run your own incoming inspection before committing to a container.

If you already know your specification and volume, send us the details and we'll turn around a quote with confirmed lead time and ship date.

Not sure whether black is the right SKU for your market, or whether you need the accelerator-free formulation? Tell us your target market and the procurement environment your buyers operate in — we'll recommend the configuration that fits.

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sales@glovemfg.com

Phone

+86 155 3755 6387

Black medical nitrile gloves factory direct sourcing with certification documentation

Full Cert Package Included

EN 455 test reports
FDA 510(k) reference
Lot-specific AQL records

OEM & ODM Services

Black Medical
Nitrile Gloves