FDA Certified Disposable Gloves

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510K Certified Disposable Nitrile Gloves

SUNLINE Supply carries a wide selection of 510K nitrile gloves to protect your employees from potential exposure to dangerous substances, contaminated surfaces and contact with patients. Our latex-free gloves are available in a range of sizes to perfectly conform to your hands for a more comfortable fit.

What Is a 510K Certification?

510K certification is a premarket review process used by the U.S. Food and Drug Administration (FDA) to ensure that medical products sold in the U.S. intended for human use are of sufficient quality. FDA 510K approval certifies that a new medical product is demonstrably safe and effective at the same levels as approved predicate products. Simply put, new products must perform at the same level as existing products on the market.

The FDA reviews information about the intended use, technological characteristics and performance data of each product and compares it to that of existing, legally marketed products of the same type before determining whether a new product is of substantial equivalence.

In addition to providing information that demonstrates the safety and effectiveness of a product, proving substantial equivalence requires products to:

  • Have the same intended use as existing products with similar characteristics.
  • Have the same intended use as existing products with different characteristics that don’t compromise safety or efficacy.

Products found to be substantially equivalent are granted 510K certification. In the case of personal protective equipment (PPE), this means that our imported 510K certified gloves have been proven to be as safe and effective as other gloves already approved for the U.S. market.

What Are The Advantages of 510K Approved Nitrile Gloves?

In some work environments, a pair of nitrile gloves may be the only thing standing between your employees and potentially dangerous substances or situations. If your PPE is low-quality, easily punctured or damaged, it may fail and your employees may be at risk of injury, illness or other unfortunate consequences. When you purchase 510 K-approved nitrile gloves, you get peace of mind knowing that your employees are adequately protected by their PPE.

Our selection of FDA-approved nitrile gloves has 510K certification, which means they have been proven to provide the same standard of safety and effectiveness as other gloves approved for sale in the U.S. This certification indicates that our gloves have undergone careful testing and investigation to determine that they are high-quality and can adequately protect your employees.

Why Choose SUNLINE Supply for 510K Gloves?

SUNLINE Supply is your dedicated supplier for 510K certified nitrile gloves and other PPE for the healthcare, commercial, educational and industrial sectors. We source our products from trusted manufacturers who are carefully selected to provide the highest-quality products. Our international team provides ongoing quality control to ensure our gloves meet our stringent standards for safety and effectiveness.

We keep our warehouses stocked with a wide selection of FDA-approved nitrile gloves in a variety of styles and sizes to meet your needs and protect your employees. Many products are ready to ship immediately and will arrive at your business or facility within 2.5 weeks of your purchase.

To request a quote for your bulk order, contact us online or give us a call at 866-781-5687.