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

Blue Nitrile Medical
Examination Gloves

The default examination glove for North American and Southeast Asian medical distribution — blue, powder-free, EN 455 and FDA 510(k) compliant, from a factory that runs nothing but nitrile.

Examination weight (0.08–0.10mm palm), textured fingertip, 100% AQL 1.5 outgoing inspection with online pinhole detection. The highest-volume SKU in our medical line — built for the accounts that reorder every 30–60 days.

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Commercial Context

Why Blue Is a Commercial Decision, Not Just a Color Choice

Blue is the default examination glove color in North American hospital procurement, outpatient clinics, dental practices, and most Southeast Asian healthcare systems. That's not a preference — it's a procurement convention that runs deep enough to appear in tender specifications and GPO contract line items. When a hospital group's supply manager writes "blue nitrile examination gloves, powder-free, EN 455 / ASTM D6319" into a contract, they're not open to substitution. Blue is the SKU.

For distributors building a medical glove line, this means blue examination gloves are the volume anchor. They're the SKU that moves every month, that fills the reorder cycle, and that your downstream customers use to evaluate whether you're a reliable supplier. Get the blue right — consistent color, consistent thickness, consistent AQL results — and the rest of the line is easier to sell.

We produce blue nitrile medical examination gloves as our highest-volume medical SKU. The blue pigment is compounded into the nitrile formulation at the mixing stage, not applied as a surface coating, so the color is consistent across the full thickness of the glove wall. Color-through compounding matters more than it sounds — surface-tinted gloves can show color variation at thin spots, which is a visual indicator of thickness inconsistency that your buyers will notice.

The examination weight profile — 0.08–0.10mm at the palm, 0.10–0.12mm at the finger — is calibrated for the standard clinical use case: GP consultations, outpatient procedures, nursing care, dental examinations. Thin enough for the tactile sensitivity that clinical staff require, thick enough to pass EN 455 barrier integrity requirements with margin.

Blue nitrile medical examination gloves in clinical use

Color-Through Compounding

Pigment mixed into the nitrile formulation — not surface-coated. Consistent color signals consistent wall thickness.

Tender-Ready SKU

Blue powder-free nitrile appears by name in GPO contracts and hospital tender specs across North America and Southeast Asia.

30–60 Day Reorder Cycle

Highest-volume medical SKU in our line. Built for accounts with predictable, recurring demand.

Clinical Weight Profile

0.08–0.10mm palm / 0.10–0.12mm finger. Tactile sensitivity for clinical staff with EN 455 barrier margin.

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-free
Color	Blue (pigment compounded into formulation)
Palm thickness	0.08–0.10mm (typical)
Finger thickness	0.10–0.12mm (typical)
Cuff thickness	0.06–0.08mm (typical)
Thickness tolerance	±0.01mm across production run
Tensile strength	≥14 MPa (pre-aging, per EN 455-2 / ASTM D6319)
Elongation at break	≥500% (pre-aging)
Length	≥240mm (EN 455-1 compliant)
Sizes	XS, S, M, L, XL
Surface finish	Textured fingertip (standard); smooth available on OEM runs
Sterility	Non-sterile
Accelerator status	Standard thiuram/carbamate cure; accelerator-free available on request
AQL inspection	1.5 (100% of outgoing lots)
Pinhole detection	Online electrical leak test, every glove
Packaging	100 pcs/box, 10 boxes/carton (standard)
Certifications	ISO 9001:2015 CE EN 455 ASTM D6319FDA 510(k)

Quality Control at a Glance

AQL Outgoing Inspection 1.5 — 100% lots

Pinhole Detection Every glove

Thickness Tolerance ±0.01mm

Certifications & Standards

EN 455

Medical gloves for single use

ASTM D6319

Nitrile examination gloves standard

FDA 510(k)

US market clearance

ISO 9001:2015

Quality management system

Need lot-specific test reports?

We provide detailed product data sheets and lot-specific test reports on request. Contact us with your volume and market requirements.

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Also in Medical Nitrile

Regulatory Readiness

Compliance Coverage: What's Already in Place for Your Markets

Blue nitrile medical examination gloves carry the most demanding certification requirements of any examination glove SKU — because they're the default specification in the highest-scrutiny procurement environments. Here's where our documentation lands.

Market	Certification	Status
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 across markets	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 — including sample orders.

Third-Party Pre-Shipment Inspection

We coordinate with SGS and Bureau Veritas as a routine part of North American and European order fulfillment when your procurement process requires it.

Already Qualified

For buyers supplying European hospital tenders or GPO contracts in the US, the certification stack is already in order. You're not waiting on us to get qualified — the paperwork is done.

Revenue Segments

Where Blue Examination Gloves Generate Recurring Revenue

Blue nitrile examination gloves are a consumable with a predictable reorder cycle. The segments below are where our distributor accounts build durable, recurring volume — not one-time orders.

Anchor Segment

Hospital and Clinical Procurement

Large hospital groups and GPOs run annual or multi-year supply contracts for examination gloves, and blue is the default specification in most North American and Southeast Asian systems. Volume is high, documentation requirements are intensive, and the qualification process takes time — but once you're on an approved vendor list, the reorder cycle runs automatically.

EN 455 and FDA 510(k) are the entry requirements; AQL consistency across every shipment is what keeps you on the list. A distributor who delivers clean incoming inspection results on every container builds a supply relationship that's genuinely difficult for a competitor to displace.

High-Frequency

Dental Distribution

A high-frequency, moderate-volume segment that reorders on monthly cycles. A mid-sized dental distributor serving 400–600 practices moves significant examination glove volume without the documentation intensity of hospital procurement.

Blue is the standard in most dental markets alongside black — carrying both gives your dental accounts a single-source option, which simplifies their procurement and increases your share of wallet. Dental accounts have grown steadily for our North American distributors — it's a segment worth building deliberately if you're not already in it.

Outpatient and Urgent Care Networks

A growing procurement segment in North America and Southeast Asia. These facilities run high patient volumes with lean procurement teams — they want a reliable supplier who can hold spec and ship on schedule, not the lowest per-box price.

Blue examination gloves are their primary consumable. Distributors who can offer consistent supply with clean documentation build sticky relationships in this segment.

Volume-Intensive

Government and Public Health Procurement

Military medical, public health agencies, and emergency stockpile programs specify blue examination gloves as the standard SKU in most markets. These contracts are volume-intensive and documentation-heavy, but the margin is stable and the reorder is predictable.

FDA 510(k) and EN 455 are the baseline requirements; our AQL 1.5 standard and lot traceability documentation are the differentiators that get you through the qualification process.

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Supplier Reliability

How We Hold Spec Across a Full Year of Orders

The commercial risk in sourcing examination gloves isn't the first container — it's the sixth. Factories that produce a clean sample set and then drift on thickness, color consistency, or AQL results on repeat orders are the reason experienced buyers qualify multiple suppliers and run incoming inspection on every shipment.

In-House Compound Formulation

We mix our own nitrile formulation in-house. Bath viscosity is monitored continuously on every line, and compound batches are tested before they go to the dipping tank. When a factory buys pre-mixed compound from a third-party supplier, batch-to-batch viscosity variation is the most common source of thickness drift across a production run.

We eliminated that variable by owning the formulation. Third-party compound looked fine on the spec sheet but produced thickness variation that didn't show up until the 20th carton of a run. Building the compounding lab was the fix.

Color Consistency at the Compound Stage

Blue pigment is added at the compounding stage, not applied post-dip. The pigment concentration is held to a tight tolerance across batches, so the blue you approve on the sample set is the blue that ships on the 50th container.

For buyers whose downstream customers use color as a visual quality indicator — and in medical procurement, they do — this matters.

Two Independent Quality Gates

Online electrical pinhole detection runs on every line, every glove, before stripping. Gloves that fail the leak test are pulled automatically and never reach the counting stage. Our outgoing AQL 1.5 inspection is a second filter on top of the inline detection.

By the time a carton is palletized, it has passed two independent quality gates — the inline pinhole test and the outgoing AQL sample. That's the mechanism behind clean incoming inspection results at your destination warehouse.

AQL 1.5

Outgoing inspection standard

100%

Inline electrical pinhole detection

2×

Independent quality gates per carton

Private Label & OEM

Customization and OEM Options

Standard blue examination gloves ship as described above. For buyers building private-label lines or requiring specification adjustments, the following customization options are available from the same facility.

Customization	Options	MOQ Note
Packaging / labeling	Private-label box design, your brand name, barcode, language	1 × 40HQ container
Color shade	Standard blue; custom Pantone shade on OEM runs	1 × 40HQ container
Surface finish	Textured fingertip (standard) or smooth	Standard MOQ
Accelerator-free formulation	Sulfur-donor cure, no detectable accelerator residue, EN 455 compliant	1 × 40HQ container
Thickness profile	Examination weight (standard) or mid-weight (0.10–0.12mm palm)	Confirm via inquiry
Carton labeling	Amazon FBA, distributor DC, or custom requirements	Standard

European Hospital & Dental Market

For buyers entering the European hospital or dental market, the accelerator-free variant is worth a specific conversation. It runs on a dedicated line with a sulfur-donor cure system — the physical properties are comparable to the standard formulation, but there is no detectable accelerator residue.

European hospital tenders increasingly carve out accelerator-free line items as separate SKUs; standard nitrile doesn't fail those tenders, it simply doesn't qualify. If you're building a European medical distribution line, this is the specification that opens procurement doors the standard blue SKU can't enter.

Private label nitrile glove packaging options for OEM buyers

Private-Label MOQ

MOQ for standard blue examination gloves with private-label packaging: one 40HQ container (approximately 2,000 boxes, 200,000 gloves at standard pack). Custom formulation projects require a development phase for formulation sign-off before production.

Discuss OEM or Custom Specifications

Logistics

Packaging, Container Loading, and Lead Times

Standard pack configuration: 100 gloves per box, 10 boxes per carton. A properly loaded 40HQ container carries approximately 2,000 cartons — 2 million gloves — without wasted cubic space. We worked out the pallet configuration years ago; it's not something we recalculate per order. This matters when you're calculating landed cost per box: a container that loads efficiently is a container where your freight cost per unit is predictable.

Pack Configuration

100 gloves per box
10 boxes per carton
~2,000 cartons per 40HQ container
~2,000,000 gloves per container

Carton Labeling Options

Amazon FBA labeling
Distributor DC labeling
Private-label specifications
Country-of-origin documentation
Packing lists & commercial invoices

Lead Times

Standard blue SKUs: 25–35 days from order confirmation
Repeat orders: Ship dates confirmed at order time
Sample orders: 5–7 business days with full certification documentation

Pre-shipment inspection coordination with SGS or Bureau Veritas is available on request. For repeat orders on established SKUs, we maintain a rolling production schedule and confirm ship dates at order time — not after production planning.

Buyer Guidance

Frequently Asked Questions

Decision-support answers for distributors, GPO buyers, and procurement teams evaluating blue nitrile examination gloves.

What is the standard thickness for blue nitrile medical examination gloves, and how does it affect clinical use?

Examination weight is 0.08–0.10mm at the palm, 0.10–0.12mm at the finger. This profile is calibrated for general clinical use — GP consultations, outpatient procedures, nursing care, dental examinations. It's thin enough for the tactile sensitivity that clinical staff require while meeting EN 455 barrier integrity requirements. If your buyers are in environments requiring higher puncture resistance (certain dental procedures, phlebotomy with higher needle-stick risk), the mid-weight profile (0.10–0.12mm palm) is the appropriate step up — not a full procedure-weight glove.

Do blue nitrile examination gloves meet FDA requirements for sale in the US market?

Yes. Our blue nitrile examination gloves carry FDA 510(k) clearance and comply with ASTM D6319 (Standard Specification for Nitrile Examination Gloves for Medical Application). The FDA 510(k) reference number and ASTM D6319 test reports are included in the documentation package that ships with every order. For buyers supplying US hospital groups, GPOs, or government procurement programs, the FDA documentation is already in place.

What is the difference between standard and accelerator-free blue nitrile gloves, and when should I specify accelerator-free?

Standard blue nitrile uses thiuram and carbamate accelerators in the vulcanization process — these are the documented cause of Type IV delayed hypersensitivity reactions in some healthcare workers. Accelerator-free uses a sulfur-donor cure system instead; the physical properties are comparable, but there is no detectable accelerator residue.

Specify Accelerator-Free When

Buyers operate in European hospital or dental procurement environments where Type IV allergy documentation is part of the tender specification.

Standard Formulation Appropriate For

North American general distribution for most accounts. Check whether hospital group or GPO contracts have accelerator-free line items.

What is the MOQ for blue nitrile medical examination gloves?

One 40HQ container for standard SKUs — approximately 2,000 boxes (200,000 gloves) at standard pack configuration (100 pcs/box, 10 boxes/carton). For private-label or OEM runs, MOQ is also one 40HQ container.

Sample orders available before full container commitment — ships within 5–7 business days with full certification documentation

How do you ensure color and thickness consistency across repeat orders?

Blue pigment is compounded into the nitrile formulation at the mixing stage — not applied as a surface coating — so color is consistent across the full glove wall and across production batches. We mix our own nitrile compound in-house, which means we control batch-to-batch viscosity directly.

In-House Compounding

Controls batch-to-batch viscosity directly, eliminating third-party batch variation.

Continuous Process Monitoring

Thickness checked at palm, finger, and cuff every two hours per line per shift. Lines drifting outside ±0.01mm tolerance stop immediately.

What causes blue nitrile examination gloves to fail AQL at destination, and how do you prevent it?

The two most common causes are pinhole failures (thin spots or micro-tears from dipping process variation) and thickness drift across a production run (from compound batch inconsistency).

Root Cause 1

Pinhole Failures

Thin spots or micro-tears from dipping process variation.

Addressed by online electrical pinhole detection on every line — failures pulled automatically before packing.

Root Cause 2

Thickness Drift

Compound batch inconsistency across a production run.

Addressed by in-house compound mixing that eliminates third-party batch variation.

Outgoing AQL 1.5 inspection is a second filter on top of inline detection. By the time a carton is palletized, it has passed two independent quality gates.

Factory-Direct Sourcing

Source Blue Examination Gloves
Direct from the Manufacturer

Blue nitrile medical examination gloves are our highest-volume medical SKU — the production process, the certification documentation, and the logistics configuration are all built around this product.

If you're evaluating us as a supplier, the fastest path is a sample order: we'll ship within 5–7 business days with the full certification documentation package for the specific production lot, so you can run your own incoming inspection before committing to a container.

If you already know your specification and volume — standard blue, AQL 1.5, EN 455 / FDA 510(k), one or more 40HQ containers — send us the details and we'll turn around a quote with a confirmed lead time.

Not sure whether standard blue or the accelerator-free variant fits your target market? Tell us which markets you're distributing into and we'll recommend the right specification based on what's moving for our existing accounts in that region.

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sales@glovemfg.com

Phone

+86 155 3755 6387

Blue nitrile medical examination gloves factory direct sourcing

5–7

Day Sample
Shipment