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

Disposable Medical
Nitrile Gloves

The volume SKU for medical distribution — powder-free disposable nitrile examination gloves with EN 455, ASTM D6319, and FDA 510(k) already in place.

0.08–0.12mm palm thickness, 100% AQL 1.5 outgoing inspection, online pinhole detection on every glove. Built for the procurement environments your downstream customers operate in.

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EN 455 ASTM D6319 FDA 510(k) 18+ Years Manufacturing

Disposable medical nitrile examination gloves — powder-free, blue, AQL 1.5 certified

Palm Thickness

0.08–0.12mm

±0.01mm tolerance

Product Overview

What This Glove Is and Where It Fits in Your Product Line

Disposable medical nitrile gloves are the examination-weight workhorse of the medical PPE market — the SKU that moves in the highest volume across GP clinics, outpatient facilities, hospital wards, dental practices, and urgent care networks. If you're building or expanding a medical distribution line, this is the product that anchors it.

Our disposable medical nitrile glove is powder-free, 0.08–0.12mm palm thickness, with a textured fingertip finish and beaded cuff. Available in blue, black, and white. It passes EN 455 Parts 1–4 for medical gloves for single use, ASTM D6319 for nitrile examination gloves, and holds FDA 510(k) clearance — the three certifications that cover medical procurement in the EU, US, Canada, Australia, and most Middle Eastern and Southeast Asian markets.

The compliance documentation ships with every order; you're not waiting on us to get paperwork in order before you can close a deal downstream.

This is the standard examination glove, not a procedure or surgical weight. The 0.08–0.12mm range is the specification tier that dominates general clinical procurement — thin enough for tactile sensitivity during examination, thick enough to pass EN 455 barrier integrity requirements. If your buyers are hospital groups, dental distributors, or outpatient clinic networks, this is the specification they're purchasing against.

View the full medical nitrile glove line — surgical, cleanroom, and laboratory variants

Medical nitrile examination gloves in clinical use — GP clinic and outpatient facility setting

EN 455

Parts 1–4

EU Medical Gloves

ASTM

D6319

US Examination

510(k)

FDA Cleared

US Market Ready

Compliance Documentation Ships With Every Order

You're not waiting on paperwork before you can close a deal downstream. All certification documents are included.

Product Data

Technical Specifications

Production-standard values for this SKU. Contact us for the detailed product data sheet and lot-specific test reports.

Full Specification Table

Parameter	Specification
Material	100% synthetic nitrile butadiene rubber (NBR)
Thickness — palm	0.08–0.12mm (typical: 0.10mm)
Thickness — finger	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)
Powder status	Powder-free
Accelerator status	Standard thiuram/carbamate cure; accelerator-free available on request
Surface finish	Textured fingertip
Cuff style	Beaded cuff, rolled
Colors	Blue, black, white (standard); custom color on OEM runs
Sizes	XS, S, M, L, XL
Sterility	Non-sterile
Packaging	100 pcs/box, 10 boxes/carton (standard)
AQL standard	1.5 (100% of outgoing lots)
Certifications	ISO 9001:2015, CE, EN 455 (Parts 1–4), ASTM D6319, FDA 510(k)

Specifications shown are production-standard values for this SKU. Contact us for the detailed product data sheet and lot-specific test reports.

Key Performance Highlights

Tensile Strength ≥14 MPa

Elongation at Break ≥500%

AQL Outgoing Inspection 100% lots

Available Colors

Blue Medical Examination

Most common clinical color

Black Medical Nitrile

Dental & specialty use

White Nitrile Medical

Clean-room & lab settings

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Get pricing for your target volume, specification, and destination market.

Get a Quote for Disposable Medical Nitrile Gloves

In-House Compounding

How We Hold ±0.01mm Thickness Across a Full Container Run

Thickness consistency is the specification that separates a reliable examination glove supplier from one that passes the sample set and drifts on production. We've seen the failure mode from the other side — buyers come to us after receiving a container where the first pallet measured 0.10mm and the last measured 0.07mm. The cause is almost always third-party compound with batch-to-batch viscosity variation. When the factory doesn't own the formulation, they can't correct for it.

We mix our own nitrile compound in-house. The compounding lab sits adjacent to the production floor, and bath viscosity is monitored continuously on every line. Each of our 8 automated dipping lines pulls ceramic hand formers through the compound bath at a controlled speed, with bath temperature held to ±1°C. Thickness is checked at palm, finger, and cuff every two hours per line per shift. If a line drifts outside the ±0.01mm tolerance, it stops — we don't run out-of-spec product and sort it later.

We've been running in-house compounding since the early years of the facility — it was the fix for the thickness variation problem we couldn't solve any other way. It's not a premium feature; it's how we make the product work.

The practical result for your supply chain: the gloves in carton 1,800 of your container measure the same as the gloves in carton 200. Your incoming inspection passes. Your downstream customers don't call with complaints about gloves that feel thinner than the last order. That consistency is what keeps you on an approved vendor list through a second and third contract cycle.

In-house nitrile compound mixing lab adjacent to production floor

Automated Dipping Lines

±1°C

Bath Temp Control

±0.01mm

Thickness Tolerance

Thickness Check Points

PalmEvery 2 hrs / line / shift

FingerEvery 2 hrs / line / shift

CuffEvery 2 hrs / line / shift

Dual Quality Gates

Pinhole Detection and AQL 1.5: The Two Quality Gates Before Your Carton Ships

Pinhole failures are the most common reason a container of medical examination gloves gets rejected at a destination port or fails incoming inspection at a hospital distribution center. The root cause is a dipping process issue — bath temperature drift, compound viscosity variation, or former surface contamination creating thin spots or micro-tears that aren't visible to the eye.

Gate 1: Online Electrical Pinhole Detection

In-Process — Every Glove

We run online electrical pinhole detection on every line, on every glove, before stripping. Each glove passes through a leak test at the stripping station. Gloves that fail are pulled automatically — they never reach the counting stage, never get packed, never reach your carton.

This is an in-process filter, not a final inspection step.

Gate 2: AQL 1.5 Outgoing Inspection

100% of Production Lots

100% of outgoing production lots go through AQL 1.5 inspection before palletization. AQL 1.5 is tighter than the AQL 2.5 default at most factories — statistically, fewer defective units per lot reach your warehouse. By the time a carton is sealed and palletized, it has passed two independent quality gates.

Lot-specific AQL documentation available on request.

Why AQL Level Matters for Hospital and GPO Supply

For buyers supplying hospital groups or GPOs with strict incoming inspection requirements, this is the specification that keeps your supply relationship intact. A container that fails incoming inspection at a hospital DC is a logistics and credibility problem that costs more than the price difference between AQL 1.5 and AQL 2.5 suppliers.

AQL 1.5

Our Standard

Tighter defect threshold — fewer units per lot reach your warehouse

AQL 2.5

Industry Default

Looser threshold — higher statistical defect rate per lot

Get a Quote & Request AQL Documentation

AQL 1.5 outgoing inspection of nitrile examination gloves before palletization

Distribution Strategy

Market Segments: Where Disposable Medical Nitrile Gloves Generate Recurring Revenue

Examination gloves are a consumable with predictable reorder cycles. The segments below are where distributor accounts build durable, recurring revenue — not one-time orders.

Hospital and Outpatient Procurement

General hospital wards, outpatient clinics, and urgent care networks are the highest-volume buyers of examination-weight gloves. Large hospital groups and GPOs run annual or multi-year supply contracts — the qualification process is documentation-intensive, but once you're on an approved vendor list, the reorder cycle is automatic. EN 455 and FDA 510(k) are the entry requirements; AQL consistency is what keeps you on the list year two and year three.

Dental Distribution

A mid-sized dental distributor serving 400–600 practices moves significant glove volume on monthly reorder cycles. Dental is less documentation-intensive than hospital procurement and the switching cost for a qualified supplier is real — practices don't change glove suppliers mid-year without a reason.

Blue and black are both active SKUs in this segment. Black has become a visual standard in many dental markets and commands a modest premium — worth carrying both if you're building a dental distribution line. The incremental inventory cost is low and the margin on black is better.

Aesthetic and Cosmetic Clinics

Growing segment in North America, Europe, and the Middle East. Black gloves are the standard. Price sensitivity is lower than hospital procurement — these buyers care about appearance and consistency more than hitting the lowest per-box price. Reorder frequency is high and the procurement process is straightforward.

Black Medical Nitrile Gloves

Home Health and Long-Term Care

Home health agencies, nursing homes, and long-term care facilities are consistent buyers of examination-weight gloves. Procurement is less centralized than hospital groups, which means more distributor touchpoints and more margin opportunity. Volume per account is moderate but the aggregate across a regional network is significant.

Occupational Health and Industrial First Aid

Examination gloves are standard in occupational health clinics and industrial first-aid stations. ASTM D6319 and FDA 510(k) cover the compliance requirements for this segment in North American markets. Reorder cycles are predictable and tied to facility headcount.

All Segments

Recurring Revenue, Not One-Time Orders

Every segment above runs on predictable reorder cycles. Qualification is the hard part — once you're in, the volume follows automatically.

Request Distributor Pricing

Compliance

Certification Coverage for Your Target Markets

The compliance documentation for this SKU is already in place for the markets where medical examination gloves are actively procured.

Market Certification Matrix

Market Certification Status

EU / EEA CE + EN 455 (Parts 1–4) Held

United States FDA 510(k) + ASTM D6319 Held

Canada Health Canada — ASTM D6319 Via ASTM

AU / NZ TGA — EN 455 Via EN 455

Middle East (GCC) SASO / GSO — EN 455 Via EN 455

Southeast Asia EN 455 widely accepted Via EN 455

Full Documentation Ships with Every Order

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

ISO 9001:2015 Quality Management

ISO 9001:2015 covers the quality management system across all production. Pre-shipment inspection coordination with SGS or Bureau Veritas is available on request — routine for North American and European accounts.

Certification documentation package for medical nitrile gloves

Two core certifications — EN 455 and FDA 510(k) — cover six major market regions. No secondary qualification process required for Canada, Australia, GCC, or Southeast Asia.

Request Documentation Package

Accelerator-Free Chemistry

Accelerator-Free Variant: The Specification That Opens European Hospital Tenders

Standard examination gloves use thiuram and carbamate accelerators in the vulcanization process. These accelerators are the documented cause of Type IV delayed hypersensitivity reactions in some healthcare workers — a growing compliance concern in European hospital procurement, particularly in Scandinavia, the UK, and Germany.

We produce an accelerator-free variant of this SKU on a dedicated line, using a sulfur-donor cure system. The physical properties — tensile strength, elongation, thickness profile — are comparable to the standard formulation. The difference is in the vulcanization chemistry: no detectable accelerator residue in the finished glove, and EN 455 compliance maintained.

For distributors supplying European hospital groups or dental networks, accelerator-free is increasingly a separate line item in tender specifications — not a premium option, but a distinct procurement category. Standard nitrile doesn't fail those tenders; it simply doesn't qualify for the accelerator-free line items. If you're building a European medical distribution line and your current catalog is all standard nitrile, this is the gap worth closing before a competitor does.

MOQ for the accelerator-free variant

One 40HQ container. Contact us to discuss specification and lead time.

Discuss Accelerator-Free Specification

Sulfur-Donor Cure System

No thiuram or carbamate accelerators. No detectable accelerator residue in the finished glove.

EN 455 Compliant

Certification maintained on the accelerator-free formulation. Physical properties comparable to standard.

Dedicated Production Line

Produced separately to prevent cross-contamination with standard accelerator-based formulations.

European Tender Qualified

Meets the accelerator-free line items in Scandinavian, UK, and German hospital procurement specifications.

Accelerator-free nitrile glove production on dedicated manufacturing line

OEM private-label nitrile glove packaging with custom branding

1×40HQ

MOQ for standard SKUs with private-label packaging

~2,000

Boxes per container at standard pack

200K

Gloves per 40HQ at standard pack count

OEM & Private Label

OEM and Private-Label: Your Brand on a Certified Examination Glove

If you're building a branded medical glove line, the production infrastructure is here. Custom color matching from Pantone reference, private-label packaging design, and specification sheets under your brand name — all handled from the same facility, no third-party subcontracting.

The certifications — EN 455, ASTM D6319, FDA 510(k) — transfer to your branded product through the standard OEM documentation process.

Custom formulation is available through our in-house compounding lab: specific elongation targets, accelerator-free chemistry, or color matching to an existing product you're replacing. Custom formulation projects require a development phase for formulation sign-off before production. We'll confirm feasibility and lead time when you send us the target specification.

Pantone color matching, private-label packaging design, branded specification sheets

EN 455, ASTM D6319, FDA 510(k) certifications transfer to your branded product via OEM documentation

Carton labeling configurable for Amazon FBA, distributor DC, or your own warehouse specifications

Country-of-origin documentation, packing lists, and commercial invoices standard

In-house compounding lab for custom elongation targets, accelerator-free chemistry, or color matching

Explore OEM/ODM Capabilities Send OEM Specification

Logistics & Procurement

Container Loading and Landed Cost

Standard pack: 100 pcs/box, 10 boxes/carton. A properly loaded 40HQ container carries approximately 2,000 cartons — 2 million gloves — without wasted cubic space. The pallet configuration is optimized for 40HQ loading efficiency; this is not something we recalculate per order.

Pack Configuration

100 pcs

per box — 10 boxes per carton. Standard across all examination-weight SKUs.

40HQ Load

2,000 cartons

≈ 2 million gloves per container. Reliable figure for landed cost calculations at standard examination weight.

Lead Time

25–35 days

From order confirmation for standard examination SKUs. Repeat orders on established SKUs ship on a rolling production schedule.

Heavier SKU Note

Surgical-weight SKUs (0.13–0.15mm) load fewer units by count per container, but the per-unit value is higher. Use the 2,000-carton figure for standard examination weight only; request a separate load plan for surgical-weight orders.

New Buyer Sample Program

Sample orders ship within 5–7 business days with the full certification documentation package for the specific production lot — before any container commitment is required.

Buyer Reference

Frequently Asked Questions

Technical and procurement questions answered for B2B buyers evaluating disposable medical nitrile gloves for distribution or institutional supply.

What is the standard thickness for disposable medical nitrile examination gloves?

For examination-weight gloves, the standard palm thickness is 0.08–0.12mm, with 0.10mm being the most common production target. Finger thickness runs slightly higher at 0.10–0.14mm. This range provides the tactile sensitivity required for clinical examination while meeting EN 455 and ASTM D6319 barrier integrity requirements. Procedure and surgical weights run thicker (0.13–0.15mm palm) — if your buyers require higher puncture resistance for extended-wear or higher-risk procedures, that's a different SKU.

What is the difference between AQL 1.5 and AQL 2.5 for medical gloves?

AQL (Acceptable Quality Limit) defines the maximum acceptable defect rate in a production lot. AQL 1.5 means a tighter threshold than AQL 2.5 — statistically, fewer defective units per lot are accepted before the lot is rejected. For medical examination gloves, the practical difference shows up at destination inspection: lots inspected to AQL 1.5 have a lower probability of containing defective units that trigger a rejection at a hospital DC or port of entry. We inspect 100% of outgoing lots to AQL 1.5, combined with online pinhole detection on every glove before packing.

Do your disposable medical nitrile gloves contain latex or powder?

No latex — these are 100% synthetic nitrile butadiene rubber (NBR), with no natural rubber latex content. Powder-free across all standard SKUs. The powder-free specification eliminates the cornstarch contamination risk in clinical environments and is the standard for medical procurement in the EU, US, and most regulated markets. A powdered variant is available for markets where powdered examination gloves remain compliant — contact us if that's relevant to your distribution territory.

What is the MOQ for disposable medical nitrile gloves?

One 40HQ container for standard examination SKUs — approximately 2,000 boxes (200,000 gloves) at standard 100 pcs/box pack configuration. For OEM/private-label runs, MOQ is also one 40HQ container. Sample orders are available before full container commitment; samples ship within 5–7 business days with the full certification documentation package.

Can I source accelerator-free disposable medical nitrile gloves from the same factory?

Yes. We produce an accelerator-free variant of this SKU on a dedicated line using a sulfur-donor cure system. EN 455 compliance is maintained; no detectable accelerator residue in the finished glove. MOQ is one 40HQ container. This is the specification for distributors supplying European hospital groups, dental networks, or any procurement environment where Type IV allergy documentation is part of the tender specification.

How do I verify the certifications before placing a container order?

Sample orders include the full certification documentation package for the specific production lot: CE declaration of conformity, FDA 510(k) reference number, EN 455 test reports, and our internal AQL records. For container orders, the same documentation ships with the goods. Pre-shipment inspection coordination with SGS or Bureau Veritas is available on request — this is routine for our North American and European accounts.

Factory-Direct Supplier

Source Disposable Medical Nitrile Gloves
Direct from the Manufacturer

glovemfg ships to North America, Europe, the Middle East, Southeast Asia, and Australia. If you're evaluating us as a supplier, the fastest path is a sample order — samples ship within 5–7 business days with the full certification documentation package, 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.

New to this product category or building out a medical distribution line? Tell us your target markets and volume expectations — we'll suggest a starter SKU mix based on what's moving for our existing distributor accounts in your region.

Request a Quote View All Medical Nitrile Gloves

sales@glovemfg.com

Phone

+86 155 3755 6387

glovemfg factory direct shipping of disposable medical nitrile gloves

5–7

Days Sample Ship

Regions Served

Full

Cert Docs Included

OEM & ODM Services

Disposable Medical
Nitrile Gloves

What This Glove Is and Where It Fits in Your Product Line