CE · EN 455 · ASTM D6319 · FDA 510(k) Certified

Latex Free Blue Nitrile Gloves — Explicit Documentation for Allergy-Protocol Procurement

Full compliance documentation — the same mechanical performance as standard exam grade, with the labeling and paperwork that allergy-managed procurement requires. Powder-free, 0.10mm palm thickness, AQL 1.5 inspected. Every box labeled and documented for latex-free supply chain requirements.

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18+ Years

Nitrile-only manufacturing

ISO 9001:2015

CE, EN 455, FDA 510(k)

1.2B pcs/yr

Annual production capacity

SKU Differentiation

What Makes This SKU Different from Standard Blue Nitrile Exam Gloves

The glove itself is not dramatically different from our standard blue nitrile exam glove — same nitrile compound, same 0.10mm palm thickness, same textured fingertip, same beaded cuff, same AQL 1.5 inspection standard. What's different is the documentation package and the label language.

Facilities managing latex allergy protocols — hospital systems, dental networks, surgical centers, food processing plants with documented worker sensitization — need more than a glove that happens to contain no latex. They need a product that is explicitly labeled and documented as latex-free, with a supply chain they can audit. Their procurement departments are managing liability, not just sourcing disposables.

When a healthcare worker with a latex allergy has a reaction, the question isn't whether the glove contained latex — it's whether the facility can demonstrate they sourced a product with documented latex-free status.

$Latex-free labeled nitrile glove box with compliance documentation$

What the Documentation Package Covers

Explicit latex-free labeling on every box and carton
Declaration of conformity specifically addressing latex content
CE declaration and EN 455 test reports documenting latex-free compound status
FDA 510(k) reference with documented latex-free status
Auditable supply chain for risk management and procurement compliance

In production since ~2015, when latex allergy management became a formal procurement requirement in European hospital tenders. Now one of our more stable reorder SKUs — buyers who need it tend to need it consistently, because the allergy protocol doesn't go away. Demand is particularly strong from hospital group purchasing organizations and dental supply distributors managing allergy protocols across large facility networks.

Standard Blue Nitrile Exam Glove vs. This Latex-Free SKU

Attribute	Standard Blue Nitrile Exam	This Latex-Free SKU
Nitrile compound	100% nitrile, no latex	100% nitrile, no latex
Palm thickness	0.10mm	0.10mm
AQL inspection	1.5	1.5
Box / carton labeling	Standard nitrile label	Explicit "latex-free" on every box & carton
Declaration of conformity	Standard	Specifically addresses latex content
Procurement audit trail	Not optimized for allergy protocols	Satisfies allergy-protocol procurement checklist
Accelerator-free option	Not standard	Available on request

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Product Data

Technical Specifications

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

Full Specification Table

Material	100% nitrile rubber — no latex, no vinyl
Color	Standard blue
Thickness (palm)	0.10 mm (typical)
Thickness (finger)	0.12 mm (typical)
Length	240 mm
Sizes	XS, S, M, L, XL
Tensile strength (before aging)	≥ 14 MPa
Elongation at break (before aging)	≥ 500%
Powder	Powder-free
Texture	Textured fingertip
Cuff	Beaded
AQL inspection standard	1.5
Latex content	None — documented and labeled
Accelerator-free option	Available on request
Packaging	100 pcs/box, 10 boxes/carton

$Automated nitrile glove dipping line with thickness tolerance control$

Why the Aging Test Matters

The tensile and elongation figures meet EN 455 Part 2 requirements both before and after accelerated aging. The aging test is where thinner or inconsistently manufactured gloves tend to fail — the polymer degrades faster at thin zones.

Our automated dipping process holds ±0.02mm tolerance across palm, finger, and cuff, which is what keeps the aging test results clean.

Key insight: A glove that passes fresh but fails aged is a glove with thickness variation — a QC problem that shows up at destination, not at outgoing inspection.

±0.02mm

Thickness tolerance (palm, finger, cuff)

AQL 1.5

Inspection standard, every lot

≥14 MPa

Tensile strength before aging

≥500%

Elongation at break before aging

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Compliance Documentation

Certifications & Latex-Free Documentation

All five certifications are held at the factory level. The CE declaration of conformity for this SKU explicitly states latex-free compound composition. EN 455 test reports document the absence of latex proteins.

Certification	Relevance to Latex-Free Procurement
ISO 9001:2015	Quality management system — required for approved vendor lists in hospital and government procurement
CE Marking	EU market access — required for European hospital and dental supply
EN 455 (Parts 1–4)	Medical gloves for single use — the baseline standard for European medical procurement
ASTM D6319	Nitrile examination gloves — North American healthcare and industrial standard
FDA 510(k)	Medical device clearance — required for US healthcare distribution channels

EU Hospital & Government Procurement

For buyers supplying hospital group tenders in the EU, the documentation package — CE declaration, EN 455 test reports, ISO 9001 certificate, and lot-specific internal test reports — is structured to satisfy both the procurement department's vendor qualification checklist and the risk management team's allergy protocol audit.

US Healthcare Distribution

The FDA 510(k) reference number is included in the standard shipment documentation. If your customer is a hospital system or a GPO with FDA documentation requirements, we provide the 510(k) reference with every order — not just on request.

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B2B Market Segments

Where This SKU Generates Repeatable B2B Volume

Latex-free documentation isn't a niche requirement — it's a baseline in several high-volume procurement channels. The segments below are where buyers are building durable, reorder-stable programs on this SKU.

$Hospital and surgical center latex-free nitrile glove supply$

Medical

Hospital & Surgical Center Supply

Hospital systems managing latex allergy protocols across their workforce specify latex-free gloves at the facility level — not just for identified allergic individuals, but as a blanket policy to eliminate exposure risk. Group purchasing organizations (GPOs) that manage supply contracts for hospital networks require explicit latex-free documentation as a vendor qualification criterion. Once you're on an approved vendor list for a GPO, the volume is substantial and the reorder cycle is predictable. EN 455 and FDA 510(k) are the entry requirements; the latex-free documentation is what keeps you on the list.

$Dental chain and DSO network nitrile glove distribution$

Dental

Dental Chain & Clinic Network Distribution

Dental professionals have among the highest rates of latex sensitization of any occupational group — a legacy of years of latex glove use before nitrile became the standard. Dental supply distributors serving multi-location chains and DSO (dental service organization) networks increasingly specify latex-free as the default, not an option. The procurement volumes per DSO network can run into the hundreds of thousands of boxes annually. This is a segment where the documentation matters as much as the price — a distributor who can provide the full latex-free compliance package has a meaningful advantage over one who can only offer a product spec sheet.

$Food processing facility latex-free glove allergen control$

Food & Industrial

Food Processing & Institutional Food Service

Food processing facilities with documented worker sensitization programs specify latex-free gloves for their production lines. Beyond worker protection, some food safety programs require latex-free documentation as part of allergen control protocols — latex proteins are classified as a potential food allergen in certain regulatory frameworks. Distributors supplying food processing plants, institutional kitchens, and catering operations in markets with allergen control requirements will find this documentation useful for their own compliance positioning.

$Pharmaceutical and laboratory latex-free nitrile glove supply$

Pharma & Lab

Pharmaceutical & Laboratory Supply

Pharmaceutical manufacturing and laboratory environments often operate under contamination control protocols that require documented material composition for every consumable. Latex-free documentation satisfies the material qualification requirements that pharmaceutical procurement teams apply to disposable PPE. The same applies to laboratory supply distributors serving research institutions and clinical labs with documented allergy management programs.

Private Label & OEM

OEM & Private Label on This SKU

The latex-free specification is one of the more common starting points for private-label programs in the medical glove category — buyers building a brand for healthcare or dental distribution want the latex-free documentation under their own label, not ours.

Custom Labeling Includes

Your brand name and logo on the box and carton
Your own product code and SKU designation
Latex-free claim language in your preferred format — wording matched to your regulatory counsel's requirements
CE declaration of conformity issued under your brand's EU authorized representative if required

The underlying product specification and certification documentation remain unchanged — you're putting your label on a fully certified, documented product, not starting from scratch.

OEM Formulation Options

Accelerator-Free Compound

For buyers targeting the European hospital market where Type IV allergy risk management is a procurement requirement. This is a separate formulation from the standard latex-free SKU — latex-free removes the latex protein risk; accelerator-free removes the chemical sensitizer risk.

Custom Thickness Profiles

Available within the 0.08–0.15mm range to match your application requirements.

Custom Cuff Length

Configurable for specific application requirements.

MOQ & Pricing

One 40HQ container — approximately 2,000 boxes

No development fee for standard labeling changes. Custom formulation projects (accelerator-free, thickness adjustment) carry the same MOQ — no trial run surcharges for established formulation types.

Tell Us Your Label Requirements

Note on Accelerator-Free

If your target market is European hospital procurement, it's worth asking about this option when you inquire. The latex-free and accelerator-free specifications address different allergy mechanisms, and some hospital procurement departments now require both. We can supply either or both from the same facility.

Logistics & Cost Planning

Packaging, Container Loading & Landed Cost

Standard packaging: 100 gloves per box, 10 boxes per carton. Carton dimensions are standardized across the blue nitrile line, so mixed-SKU loading with other blue nitrile SKUs is supported without losing container efficiency.

Container Type	Cartons Loaded	Gloves (pcs)	Boxes
20GP	~900 cartons	~900,000 pcs	~9,000 boxes
40HQ	~2,000 cartons	~2,000,000 pcs	~20,000 boxes

DC-Ready Configuration

The 100 pcs/box configuration is standard for distributor DC receiving and healthcare facility storeroom management. No repackaging required at your warehouse.

Documentation Ships with Every Order

The latex-free documentation — CE declaration, EN 455 test reports, FDA 510(k) reference — ships in the standard documentation package with every container order.

Third-Party Pre-Shipment Inspection

Pre-shipment inspection by SGS or Bureau Veritas is available if your procurement process requires third-party verification. We coordinate directly with the inspection agency; the cost is factored into the quote.

Ready to calculate your landed cost?

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Buyer Guidance

Frequently Asked Questions

What is the difference between latex-free nitrile gloves and standard nitrile gloves?

All nitrile gloves are made from synthetic rubber — they contain no natural latex by definition. The difference with an explicitly latex-free SKU is documentation and labeling. Standard nitrile gloves may be manufactured on lines that also process latex products, or in facilities that handle latex materials, creating cross-contamination risk. Our latex-free blue nitrile gloves are produced in a latex-free manufacturing environment — no latex materials are used anywhere in our facility — and the product is explicitly labeled and documented as latex-free. For procurement departments managing allergy protocols, that documented status is what satisfies the compliance requirement, not just the product composition.

Do latex-free nitrile gloves meet EN 455 for European medical procurement?

Yes. EN 455 (Parts 1–4) covers medical gloves for single use and includes requirements for freedom from holes, physical properties, biological evaluation, and shelf life. Our latex-free blue nitrile gloves meet EN 455 across all four parts. The CE declaration of conformity for this SKU explicitly documents the latex-free compound composition. For European hospital tenders and dental supply contracts, the EN 455 test reports and CE declaration are the documents procurement departments will request — both are available with sample orders.

What is the difference between latex-free and accelerator-free nitrile gloves?

Latex-free addresses the risk of natural rubber latex protein allergy (Type I hypersensitivity). Accelerator-free addresses the risk of chemical accelerator allergy (Type IV hypersensitivity) — a reaction to the thiuram and carbamate compounds used in standard nitrile vulcanization. A latex-free glove can still contain accelerators; an accelerator-free glove is latex-free by definition but also removes the chemical sensitizer risk. For most procurement programs, latex-free is sufficient. For European hospital procurement departments managing healthcare worker sensitization programs, accelerator-free is increasingly required. We produce both from the same facility — ask us about the accelerator-free option if your target market requires it.

What certifications are required to sell latex-free nitrile gloves into US healthcare?

FDA 510(k) clearance is the primary requirement for medical examination gloves sold into US healthcare channels. ASTM D6319 is the performance standard that the 510(k) references. For latex-free claims specifically, the FDA requires that the product be manufactured in a latex-free environment and that the latex-free status be documented in the 510(k) submission. Our FDA 510(k) clearance covers the latex-free nitrile formulation — the reference number is included in the standard shipment documentation for every order.

What is the MOQ for latex-free blue nitrile gloves, and are samples available?

MOQ for standard latex-free blue nitrile gloves is one 40HQ container, approximately 2,000 boxes (200,000 gloves at 100 pcs/box). For new buyers, we support sample orders before full container commitment — samples ship within 5–7 business days with the full certification and latex-free documentation package. Mixed-SKU loading with other blue nitrile SKUs is supported from the same container MOQ.

Source Latex-Free Blue Nitrile Gloves

Sourcing for a healthcare, dental, or allergy-protocol procurement program? Send us your target volume, destination market, and documentation requirements — we'll confirm certification coverage, arrange samples, and send a detailed quote.

Get a Quote sales@glovemfg.com +86 155 3755 6387