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FDA 510K and CE Approved White Nitrile Box Exam Gloves - Standard 6mil

Quantity:
SKU: 502320507X
Model: ABC-DG01

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Product Details

White Nitrile Box Exam Gloves - Standard 6mil

Model: ABC-DG01 | 100 Pcs/Box | Thickness: 6mil

Product Summary

These white disposable nitrile exam gloves are designed for medical examination, food processing, and general purpose protection. Each box contains 100 gloves (6mil thickness) made from high-quality nitrile material. Our gloves are FDA 510(K) cleared, CE marked under EU MDR, and comply with EN455, ASTM D6319, and GB food safety standards. They are powder-free, latex-free, and offer excellent barrier protection against pathogens and chemicals.

Key Selling Points

  • Regulatory Compliance: FDA 510(K) cleared (K230542), CE (EU MDR Class I), EN455+EN374 tested, ensuring acceptance in global medical markets.
  • Food Grade Safety: Tested to GB 4806.11-2016 and Japan MHLW No.370 for food contact; safe for food handling.
  • 6mil Thickness & 100% Inspection: 6mil provides reliable tear resistance; each glove undergoes 100% inspection to AQL 1.5.
  • Powder-Free & Latex-Free: Eliminates risk of Type I allergies; suitable for sensitive skin and clean environments.
  • Versatile Applications: Ideal for hospitals, clinics, food processing, beauty salons, and tattoo studios.

Technical Specifications

ParameterValue
MaterialNitrile
Thickness6mil (0.15mm)
Packaging100 pcs/box
ColorWhite
AQL1.5
StandardsFDA 510K, CE (EU) 2017/745, EN455-1/-2/-3, ASTM D6319-19, GB 10213-2006, GB 4806.11-2016
CertificationsISO 13485, 510(K) K230542, EUDAMED SRN: CN-MF-00039003
PriceUSD 0.02-0.03/piece (FOB)
MOQ1000 pieces (bulk) or 10 boxes

Models and Options

Standard model: ABC-DG01 (white, 100 pcs/box). Also available in blue color (model ABC-DG01-BL) and alternative packaging: individual sealed packs (400 bags MOQ), bulk 1000 pcs. Custom logo and carton printing available.

Materials and Structure

Made from premium synthetic nitrile (NBR) via secondary dipping technology, ensuring uniform thickness and high tensile strength. Powder-free, low protein content. Ambidextrous design with textured fingertips for enhanced grip. Beaded cuff for easy donning.

Applications

  • Medical examination and patient care
  • Food processing and handling
  • Beauty salons, tattoo studios, spa
  • Laboratory and light industrial tasks

Customization

OEM/ODM available: custom color, thickness (4-8mil), logo printing (first direct printing on gloves), custom packaging (box, bag, or 2-pack). Carton labeling per buyer requirements. Contact us for details.

Case Study

Client: Global Medical Distributor
Application: Hospital supply chain
Order: 800,000+ boxes (20 containers), recurring over 2+ years
Result: Sustained repeat orders due to FDA 510K clearance and consistent quality.

Frequently Asked Questions

Q: Are these gloves suitable for surgical use?

No, these are examination gloves, not sterile surgical gloves. They are suitable for non-surgical medical exams and procedures.

Q: What is the MOQ for boxed gloves?

MOQ is 1000 pieces (10 boxes of 100 pcs) for bulk orders. For sample or small trial, please contact us.

Q: What delivery methods do you support?

FOB Shenzhen/Guangzhou, CIF available, and express for samples. Payment: T/T (30% deposit), Trade Assurance, L/C for large orders.

Q: What certifications do these gloves have?

They are FDA 510(K) cleared, CE marked under EU MDR, tested to EN455, EN374, ASTM D6319, GB 10213, and GB 4806 food contact standards.

Q: Can I have custom packaging with my logo?

Yes, we offer OEM/ODM with custom logo printing on gloves and custom box/bag design.

Q: What is the lead time?

Typical lead time is 15-25 days depending on order quantity. Details confirmed upon order.

Inquiry Information

For pricing, sample request, or custom specifications, contact:
Anna (Regional Manager - Americas)
Tel/WhatsApp: +86 13360405912
Email: merchandiser@szanboson.com
Website: szanboson.com

Product Images

White nitrile box exam gloves FDA 510K approved 6mil
Box of white nitrile gloves 100 pcs
White nitrile exam gloves close-up texture
Pile of white nitrile gloves for medical use