EN 455 & ASTM D6319 Certified Manufacturer

Blue Nitrile Exam Gloves — Factory Direct

Examination-grade blue nitrile gloves built to satisfy hospital group tenders and dental chain supply contracts in both European and North American markets. 0.10mm palm thickness, textured fingertip, beaded cuff — manufactured on 8 automated dipping lines with 100% AQL 1.5 outgoing inspection and full EN 455, ASTM D6319, and FDA 510(k) documentation.

EN 455 ASTM D6319 FDA 510(k) ISO 9001:2015 CE AQL 1.5 Powder-free OEM from 1 container MOQ
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Product Positioning

What Separates Exam Grade from General-Purpose Blue Nitrile

Blue nitrile exam gloves occupy a specific position in the product line — they're not the lightest SKU we make, and they're not the heaviest. The exam grade is defined by its certification coverage and the mechanical performance thresholds those certifications require: EN 455 for European medical procurement, ASTM D6319 for North American healthcare and industrial channels, and FDA 510(k) clearance for US healthcare distribution.

A glove that doesn't carry all three is a general-purpose disposable, not an examination glove — and that distinction matters when your buyer is filling out an approved vendor list for a hospital group or a dental chain.

The specification profile reflects the examination use case: 0.10mm palm thickness gives the tactile sensitivity that clinical users expect, the textured fingertip improves grip on instruments and packaging, and the beaded cuff prevents rollback during donning. These aren't arbitrary design choices — they're the parameters that come up repeatedly in hospital procurement specifications, and we've been producing to them since the early years of the factory.

For distributors, the exam grade is the SKU that opens healthcare accounts. Once you're on an approved vendor list with the right documentation, reorder cycles are predictable and volume is substantial. The certification paperwork is the entry ticket; the consistency of the product across orders is what keeps the account.

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Blue nitrile exam gloves in clinical examination setting showing textured fingertip and beaded cuff
Triple Certification

EN 455, ASTM D6319, and FDA 510(k) — all three required for healthcare approved vendor lists.

0.10mm Palm

Clinical tactile sensitivity with textured fingertip for instrument and packaging grip.

AQL 1.5

100% of production lots inspected to AQL 1.5 — the standard healthcare procurement requires.

Exam Grade vs. General-Purpose: The Defining Differences

Criterion Exam Grade (This SKU) General-Purpose
EN 455 (EU Medical) Yes No
ASTM D6319 (NA Healthcare) Yes No
FDA 510(k) Clearance Yes No
AQL Inspection 1.5 (100% of lots) 2.5 or 4.0 typical
Hospital Approved Vendor Lists Eligible Not eligible
Dental Chain Supply Contracts Eligible Not eligible
Full Specification Profile

Technical Specifications

Request Data Sheet & Sample

Physical & Mechanical Parameters

Parameter Specification
Glove type Powder-free nitrile examination glove
Color Standard blue (custom shades available for OEM)
Palm thickness 0.10 mm (typical)
Finger thickness 0.12 mm (typical)
Cuff thickness 0.08 mm (typical)
Thickness tolerance ±0.02 mm across palm, finger, and cuff
Length 240 mm (standard)
Sizes XS, S, M, L, XL
Tensile strength (before aging) ≥ 14 MPa
Tensile strength (after aging) ≥ 11 MPa
Elongation at break (before aging) ≥ 500%
Elongation at break (after aging) ≥ 400%
AQL inspection standard 1.5 (100% of production lots)
Texture Textured fingertip (standard); full palm texture available on request
Cuff style Beaded cuff
Powder Powder-free
Accelerator-free option Available (dedicated line, same MOQ)
Packaging 100 pcs/box, 10 boxes/carton
Certifications
EN 455 ASTM D6319 FDA 510(k) CE ISO 9001:2015

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.

Close-up of blue nitrile exam glove showing 0.10mm palm thickness and textured fingertip detail

Thickness at a Glance

Palm 0.10 mm
Finger 0.12mm
Cuff 0.08 mm

Tolerance: ±0.02 mm across all zones

Mechanical Performance

≥ 14 MPa tensile
Before aging (EN 455 / ASTM D6319 threshold)
≥ 11 MPa tensile
After aging — shelf-life integrity confirmed
≥ 500% elongation
Before aging — donning and snap-back performance
≥ 400% elongation
After aging — retained flexibility over shelf life
Accelerator-Free Available

Dedicated production line. Same MOQ as standard exam grade. Suitable for users with Type IV chemical sensitivity protocols.

Enquire about accelerator-free
Need lot-specific test reports?

We supply full product data sheets and lot-specific AQL 1.5 test documentation for procurement and compliance teams.

Request a data sheet and sample
Process Control

How We Hold 0.10mm Across the Full Glove — Not Just at the Palm

Thickness consistency is the specification that determines whether a container of exam gloves passes or fails AQL at the destination port. A glove that measures 0.10mm at the palm but drops to 0.07mm at the fingertip is within nominal spec on paper — and it will fail the tensile and elongation tests that EN 455 and ASTM D6319 require, because the thin zones are where the glove tears under stress. That's a container your buyer can't sell, and a claim that comes back to you.

We hold ±0.02mm tolerance across the full glove — palm, finger, and cuff — through closed-loop process controls on our automated dipping lines: bath temperature maintained at ±1°C, compound viscosity monitored continuously, dipping speed consistent across the full conveyor cycle. These aren't manual adjustments. The process runs the same way on the first glove of a shift and the last glove of a 24-hour run.

The in-house compounding lab is the other half of the equation. We mix our own nitrile compound, which means we control the viscosity profile that determines how the compound coats the ceramic former at each dip pass. Factories buying pre-mixed compound from third-party suppliers are adjusting dipping parameters to compensate for compounding variables they don't control — when their batch consistency drifts, their AQL results drift with it. We don't have that problem because we own the formulation.

We've had buyers come to us after a container rejection at Rotterdam or Los Angeles. In most cases, the root cause was thickness variation at the fingertip — not a visible defect, not a pinhole, just a thin zone that failed tensile under test conditions. It's a process control problem, and it's entirely preventable.

For distributors managing supply agreements with hospital groups or dental chains, this consistency is what protects your account relationship. Your downstream customers don't audit our QC process — they open boxes and use gloves. Every box needs to perform the same way.

Automated nitrile glove dipping line with closed-loop process controls
±0.02mm
Full-Glove Tolerance
Palm, finger & cuff
±1°C
Bath Temperature
Continuous monitoring
100%
Pinhole Detection
Online, pre-strip

QC Layer Architecture

1
In-House Compounding
Viscosity profile controlled at source — no third-party batch drift
2
Closed-Loop Dipping Lines
Temperature, viscosity, and speed locked across full conveyor cycle
3
Online Electrical Pinhole Detection
Every glove tested before stripping — failures pulled automatically
4
100% AQL 1.5 Outgoing Inspection
Final verification layer — not the primary catch mechanism
Documentation

Certification Coverage for Medical & Healthcare Procurement

Blue nitrile exam gloves from glovemfg carry the full documentation set required for medical procurement in both European and North American markets.

EN 455
Parts 1–4

Medical gloves for single use. The baseline requirement for European hospital tenders — without it, your product doesn't get onto the approved vendor list, regardless of price.

EU Hospital & Clinical
ASTM D6319
Nitrile examination gloves

Covers the North American side for healthcare and industrial channels.

North American Healthcare
FDA 510(k)
Medical device clearance

The document US healthcare distributors need when their hospital customers ask for it — and they will ask.

US Healthcare Distribution
CE Marking
Product conformity

European Union market access conformity declaration.

EU Market Access
ISO 9001:2015
Quality management system

Required for global approved vendor list qualification by ISO 9001 auditors.

Global AVL Qualification
Full Documentation Package

CE declaration of conformity, FDA 510(k) reference number, ISO certificate, and lot-specific test reports ship with every sample order.

Structured to satisfy both ISO 9001 auditors and FDA import reviewers — for public health tenders in EU member states and US government healthcare contracts.

Request Certification Documentation
Certification Standard Market Application
EN 455 Medical gloves for single use (Parts 1–4) European hospital, dental, and clinical procurement
ASTM D6319 Nitrile examination gloves North American healthcare and industrial channels
FDA 510(k) Medical device clearance US healthcare distribution
CE Marking Product conformity European Union market access
ISO 9001:2015 Quality management system Global approved vendor list requirements
Distribution Channels

Market Segments Where This SKU Generates Durable Volume

Blue nitrile exam gloves are not a commodity SKU in the sense that any distributor can sell them anywhere. The exam grade is specifically positioned for channels where certification documentation is a procurement requirement — and those channels tend to be high-volume, high-reorder, and relatively price-stable once you're on the approved vendor list.

Hospital group procurement and health system supply
Hospital & Health System

Hospital Group & Health System Supply

Hospital procurement departments run on annual or biannual tender cycles. Volume per contract ranges from hundreds of thousands to millions of boxes depending on the health system's size. EN 455 and FDA 510(k) are non-negotiable entry requirements — without them, you don't get to bid. Once you're in, reorder rates are high and switching costs are real: changing glove suppliers requires re-qualification, which procurement departments avoid unless there's a compelling reason. The exam grade is the SKU that gets you into this segment.

Dental chain and clinic network centralized procurement
Dental & Clinic Networks

Dental Chain & Clinic Network Distribution

Dental chains and multi-location clinic networks purchase on centralized procurement schedules, typically quarterly or semi-annually. Volume per account is lower than hospital groups but the account base is broader — a regional dental distributor might supply 200–500 clinic locations. EN 455 compliance and consistent box-to-box performance are the primary selection criteria. Dental procurement managers are particularly sensitive to glove fit and tactile feel — the 0.10mm exam grade with textured fingertip is the specification that satisfies clinical staff feedback, which is what drives the procurement renewal decision.

Medical supply distributors serving North America physician offices
North America Distribution

Medical Supply Distributors Serving North America

US and Canadian medical supply distributors supplying physician offices, urgent care centers, and outpatient clinics need FDA 510(k) documentation as a baseline. ASTM D6319 compliance is the technical standard their customers reference. This channel runs on distributor catalog programs — once your SKU is in the catalog with the right documentation, it generates passive reorder volume without active selling effort on each transaction.

Overseas healthcare procurement Middle East Southeast Asia Australia
Export Markets

Overseas Healthcare Procurement Programs

Middle East, Southeast Asia, and Australian healthcare procurement increasingly requires EN 455 or equivalent documentation for hospital supply contracts. Distributors building regional healthcare supply programs in these markets need a supplier who can provide both the product and the compliance documentation in a format that satisfies local procurement requirements. Our export experience across these four regions means the documentation package is already structured for the formats these markets expect.

Tell us your target market and volume — get a quote
OEM & Private Label

Customization Options for OEM & Private Label Programs

The exam grade is one of the most commonly customized SKUs in our blue nitrile line — healthcare distributors building private-label programs want the certification coverage of the exam grade combined with their own brand identity.

Customization Dimension Options MOQ Impact
Color Standard blue; custom shades (Pantone-matched) via in-house compounding lab Custom color: same MOQ as standard
Accelerator-free compound Available on dedicated line; EN 455 compliant, no detectable accelerator residue Same MOQ
Thickness profile Standard 0.10mm palm; heavier profiles (0.12–0.15mm) available Same MOQ
Texture Fingertip texture (standard); full palm texture on request Same MOQ
Cuff length 240mm standard; extended cuff (270mm) available Confirm via inquiry
Box labeling Full custom artwork, your brand, your language, your regulatory text Handled in-house
Carton marking Custom carton print, barcode, country-of-origin labeling Handled in-house
OEM private label packaging handled in-house
MOQ Summary

MOQ for standard blue nitrile exam gloves under your private label: one 40HQ container (approximately 2,000 boxes, 200,000 gloves). Custom formulation projects — accelerator-free compound, Pantone-matched color, adjusted thickness profile — carry the same MOQ. We don't charge development fees for established formulation types.

In-House Labeling Advantage

Labeling and packaging are handled entirely in-house. When you update your label artwork, the change goes through our production system directly — no third-party print supplier, no subcontractor queue. For distributors managing multiple SKUs under a private-label program, this matters for version control and lead time.

Outline your OEM requirements — get a program proposal
Blue Nitrile Line

Related Blue Nitrile SKUs

If the exam grade isn't the right fit for your channel, the other SKUs in the blue nitrile line cover adjacent specifications.

Blue Medical Examination Nitrile Gloves

FDA 510(k) as the primary credential, cleanroom-standard packing, for US healthcare distribution channels.

Medical

Latex Free Blue Nitrile Gloves

Explicit latex-free labeling and documentation for facilities with allergy management protocols.

Allergy-Safe

Disposable Blue Nitrile Gloves

General-purpose grade, 0.08–0.10mm, broadest application coverage, most competitive landed cost.

General Purpose

Blue Nitrile Cleaning Gloves

Heavier wall (0.10–0.12mm) for cleaning and sanitation channels.

Heavy Duty

Textured Blue Nitrile Gloves

Full palm texture for wet and oily surface applications.

Textured Grip View Full Blue Nitrile Line All SKUs, specs & certifications
Manufacturer Since 2007

About the Factory Behind This SKU

Weifang Glovemfg Medical Products Co., Ltd. has manufactured nitrile gloves since 2007 from our 18,000 m² facility in Gaomi, Weifang.

The blue nitrile exam grade has been a core production SKU since the beginning — it's the product that established our EN 455 and FDA 510(k) credentials and the one we've shipped the most containers of over 18 years.

Learn About Our Facility
2007
Founded
18,000
m² Facility
8
Dipping Lines
1.2B
Pieces / Year
EN 455 FDA 510(k)
In-House Compounding Lab

Ready to Evaluate Blue Nitrile Exam Gloves?

Send us your target market, volume estimate, and any certification requirements — we'll confirm the documentation package, send a detailed quote, and arrange samples.

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