CE & ISO 13485 Certified Medical Manufacturer

Latex Surgical Gloves Manufacturer & OEM Supplier

Q: What is your minimum order quantity (MOQ) for latex surgical gloves?

For standard neutral packaging, order minimums start at 100 master cartons. For OEM private-label branding with custom dispenser box artwork and inner pouches, the MOQ is typically one 20ft container per SKU size mix.

Q: Which regulatory certificates are provided with export shipments?

Every shipment is accompanied by an ISO 13485:2016 Quality Management Certificate, CE Declaration of Conformity (MDR), Certificate of Free Sale (FSC), batch Certificate of Analysis (CoA), radiation/EO sterilization validation records, and EN 455 test reports.

Q: How do you ensure low allergen and protein levels in latex gloves?

Our gloves undergo extensive multi-stage hot water leaching and polymer coating on continuous dipping lines. Powder-free variants are online-chlorinated to extract water-soluble proteins, maintaining total extractable protein levels below 50 µg/dm².

Q: What are your production lead times and shipment terms?

Repeat container orders ship within 3 to 4 weeks. First-time private-label orders require 4 to 6 weeks for packaging proofing, sterilization validation, and pre-shipment inspection release. We quote FOB, CIF, and DDP terms.

High-Tactile Sensitivity Sterile Surgical & Examination Gloves Engineered for Global Hospital Procurement and Tender Distribution.

Home » Products » Gloves

AQL 1.5 Quality StandardRigorous pinhole & water-tight testing per ISO 2859-1

Factory Direct SupplyManufactured at Sonepat integrated plant, India

Global Regulatory DossiersCE MDR, ISO 13485, EN 455 & ASTM D3577 compliant

OEM & Custom PackagingPrivate label branding, multilingual boxes & sterile pouches

Medical Grade Barrier Protection

Direct-from-Factory Medical & Latex Surgical Gloves Exporter

When surgical teams step into the operating theatre, sterile gloves serve as the primary critical barrier against blood-borne pathogens and cross-contamination. At Lars Medicare, our medical glove manufacturing processes are engineered to uphold uncompromising barrier integrity, exceptional tensile strength, and superior tactile sensitivity during high-risk surgical procedures.

As an established Indian medical device manufacturer with over two decades of international export experience, we supply government health authorities, private hospital networks, and medical distributors across more than 100 countries. Our latex gloves undergo multi-stage hot water leaching processes to minimize extractable protein levels, lowering the risk of Type I latex skin allergies while maintaining peak elasticity.

Product Portfolio

Latex Surgical & Examination Gloves Range

Manufactured under strict ISO 13485 cleanroom standards for operating theatres, intensive care units, and routine diagnostic handling.

Sterile Latex Surgical Gloves

Anatomically shaped left and right hand design with curved fingers to reduce hand fatigue during extended surgical procedures. Featuring micro-textured surfaces for enhanced wet and dry instrument grip.

Sterilization: Gamma Radiation or Ethylene Oxide (EO) validated cycles
Finish Options: Micro-textured or smooth; Lightly Powdered / Powder-Free Polymer Coated
Cuff Design: Reinforced beaded cuff to prevent roll-down and tearing during donning
Size Range: 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 (Color-coded inner wrappers)
Standard Compliance: ASTM D3577, EN 455 (Parts 1-4), IS 13422

Latex Examination Gloves (Non-Sterile)

Ambidextrous medical gloves engineered for routine patient handling, laboratory testing, dental examinations, and clinical diagnostics. Designed for rapid donning and reliable tactile feedback.

Design: Ambidextrous fit with textured fingertips for precise instrument control
Powder Options: Powdered (USP grade cornstarch) or Powder-Free online chlorinated
Barrier Integrity: AQL 1.5 inspection standards for freedom from pinholes
Size Range: Small (S), Medium (M), Large (L), Extra Large (XL)
Standard Compliance: ASTM D3578, EN 455-1/2/3/4 standards

Technical Benchmarks

Comprehensive Product Specifications

Key technical parameters for hospital procurement evaluation, technical dossier submission, and tender compliance.

Technical Parameter	Sterile Latex Surgical Gloves	Latex Examination Gloves
Primary Material	High-Grade Natural Rubber Latex Compound	High-Grade Natural Rubber Latex Compound
Sterility Status	Sterile (EO / Gamma Sterilized)	Non-Sterile
Acceptable Quality Level (AQL)	AQL 1.0 - 1.5 for Freedom from Holes	AQL 1.5 for Freedom from Holes
Overall Length (mm)	≥ 280 mm - 300 mm	≥ 240 mm
Single Wall Thickness (Palm)	0.18 mm to 0.22 mm	0.10 mm to 0.14 mm
Tensile Strength (Before Aging)	≥ 24 MPa	≥ 18 MPa
Ultimate Elongation (Before Aging)	≥ 750%	≥ 650%
Extractable Protein Level	< 50 μg/dm² (Powder-Free)	< 50 μg/dm² (Powder-Free)
Shelf Life & Storage	5 Years in cool, dry conditions away from UV light	3 to 5 Years under standard storage conditions

Manufacturing Rigor & Quality

Controlled Production & Quality Assurance Systems

Quality in single-use medical consumables cannot be inspected into a product at the final container stage—it must be built into every step of raw material selection, latex compounding, dipping, leaching, and sterilization validation.

1. Automated Dipping & Extended Leaching

Our manufacturing facility utilizes continuous automated dipping lines with extended hot water leaching cycles to wash away residual chemical accelerators and natural rubber latex proteins, minimizing skin sensitization risk.

2. 100% Water-Tight & Air-Inflation Testing

Surgical gloves undergo rigorous water-tight testing and physical air-inflation checks according to ISO 2859-1 sampling plans to maintain an AQL of 1.0 to 1.5 before automated pouch packaging.

3. Full Batch Traceability & Dossier Support

Every consignment ships with full quality documentation: ISO 13485 Certificate, CE Declaration of Conformity, Batch Certificate of Analysis (CoA), Free Sale Certificate (FSC), and Sterilization Validation reports.

OEM & Private Label Capabilities

We specialize in private label manufacturing for international medical brands, hospital group distributors, and national healthcare tenders:

✓ Custom dispenser box artwork & outer carton printing
✓ Multilingual IFU (Instructions for Use) & barcode integration
✓ GS1 / UDI-compliant labeling for international compliance
✓ Customized inner peel-pouch paper & film configurations

Our regulatory team prepares registration technical files formatted specifically for fast product approval across EU, Latin America, Middle East, Africa, and CIS regional markets.

Procurement Advisory

Selecting Latex vs. Synthetic Nitrile Gloves

Objective technical guidance for healthcare procurement officers, hospital administrators, and tender committee heads.

Tactile Sensitivity & Elasticity

Natural rubber latex offers unmatched elasticity and ergonomic memory, making it the premier choice for microsurgery, ophthalmology, and delicate procedures where tactile feedback is critical to surgeon precision.

Barrier Integrity & Tear Resistance

Natural latex exhibits superior elasticity under stress and self-sealing characteristics under micro-punctures. For latex-sensitive environments, synthetic Nitrile gloves are recommended for chemical resistance.

Cost-Performance for Tenders

High-capacity automated production yields competitive unit costs for high-volume hospital tenders without compromising AQL 1.5 quality standards, ensuring predictable supply chain landed costs.

Buyer Knowledge Base

Frequently Asked Questions for Importers & Procurement

Clear answers regarding order minimums, shipping terms, packaging options, and quality documentation.

What is your minimum order quantity (MOQ) for latex surgical gloves?

For standard neutral packaging, order minimums start at 100 master cartons. For OEM private-label branding with custom dispenser box artwork and inner pouches, the MOQ is typically one 20ft container per SKU size mix to optimize tooling and printing setups.

Which regulatory certificates are provided with export shipments?

Every shipment is accompanied by an ISO 13485:2016 Quality Management Certificate, CE Declaration of Conformity (MDR), Certificate of Free Sale (FSC), batch Certificate of Analysis (CoA), radiation/EO sterilization validation records, and EN 455 test reports.

How do you ensure low allergen and protein levels in latex gloves?

Our gloves undergo extensive multi-stage hot water leaching and polymer coating on continuous dipping lines. Powder-free variants are online-chlorinated to extract water-soluble proteins, maintaining total extractable protein levels below 50 μg/dm².

What are your production lead times and shipment terms?

Repeat container orders ship within 3 to 4 weeks. First-time private-label orders require 4 to 6 weeks for packaging proofing, sterilization validation, and pre-shipment inspection release. We quote FOB, CIF, and DDP terms.

Can qualified buyers request evaluation samples before placing container orders?

Yes. Complimentary sample boxes with full technical data sheets and CoA documentation are available for qualified medical distributors, hospital purchasing committees, and tender agents. Delivery is arranged via express courier.

Partner with a Certified Manufacturer

Ready to Source Direct-from-Factory Medical Gloves?

Get detailed technical data sheets, landed price quotes (FOB/CIF), and container packing specifications within 24 hours.

Send an Inquiry