Standards

Doing Everything with Quality

Globally Recognized Standards

Recognized for supporting medical institutions and thus helping to save lives, Kemei continues to produce disposable gloves that follow and even surpass ASTM and other international standards.

Rigorous testing and clean work environments are key to our success and we innovate in our production processes to deliver responsive solutions to your medical supply needs.

p13 3 s02 img
  • ASTM
  • EN374
  • EN455
  • CE
  • EN ISO 13485
  • Environmental

ASTM

D3577

A standard applied for rubber surgical gloves, the D3577 mandates that the inside and outside surfaces of the gloves are free from tact and holes. Along with physical features ensuring a comfortable fit, our rubber gloves are tested for their protein content, sterility, stress at elongation, and tensile strength to assess their conformity to requirements.

D5151

The D5151 standard applies to a variety of non-sterile examination gloves made of latex, PVC, and nitrile materials. This testing standard uses pressure leak testing and water leak testing to see how much water is allowed to leak in the glove that can damage the glove when in use.

D5250

Used for testing the performance of non-sterile PVC examination gloves, the D5250 standard evaluates to see if the gloves are free of talc and holes and possess great sterility and tensile strength throughout testing. Safe amounts of some lubricants may be added.

D5712

Within our advanced laboratories, we apply the D5712 to prevent allergens by reducing protein levels in our non-sterile latex examination gloves. Determining the protein levels of latex involves extracting water-soluble proteins that are concentrated and quantified to acquire the needed results.

D6124

Determining the amount of powder on the glove samples, the D6124 standard is for surgical gloves and non-sterile latex, PVC, and nitrile examination gloves. For powdered gloves, the mass we look into may be water-insoluble residue, donning powder, and other release agents found after the manufacturing process.

D6319

Similar to the D3578 standard for rubber examination gloves, D6319 checks for the tensile strength and ultimate elongation of non-sterile examination gloves to test their performance and comfort of use.

D6499

In preventing latex and other allergies, we follow D6499 standards to detect proteins and localized urticaria and control the amount of protein present in our surgical gloves. Testing protein levels ensures the safe use of our gloves and proactively protects against various allergies and contaminants.

F88

To test the sealing strength of our packaging material for our surgical gloves, we follow F88 standards to measure how much the package seal resists separation. This way, we see how efficient our packing machines are in sealing our pouches consistently.

F1929

In preventing the entry of contaminants, the F1929 standard identifies leakage formed on the packaging. Testing methods include the break test and creep test, both of which inflate packaging to test the adhesive bond and overall strength of the packaging.

Other Standards

EN374

Focused on protecting gloves from harmful chemicals for healthcare worker safety, this standard provides a glove rating from A to C depending on the number of chemicals the gloves protect against. With thorough testing, our non-sterile PVC and nitrile examination gloves have been verified as Type A, resisting around 6 test chemicals for a period of over 30 minutes when worn.

EN455

Regulating single-use, non-sterile nitrile examination gloves are the EN455 standards, which ensure that gloves are free of holes, have adhered to physical requirements, and follow a determined shelf life. Physical resistance is tested to prevent leakage and the entry of harmful bacteria and contaminants. Additionally, we guarantee that the glove material itself is non-toxic.

CE

The CE marking on our surgical gloves and other medical products guarantees their safe use and that our production conforms to EU standards. All of our surgical gloves follow European health and safety standards, ensuring their entry and delivery into European markets.

EN ISO 13485

Our quality management systems fulfill this standard as we can produce medical devices consistent to market requirements. With our in-house manufacturing processes and one-stop solutions, we oversee the overall production cycle and deliver technical support based on our longtime expertise in the industry. As your EN ISO 13485 certified manufacturer, Kemei provides value-added services to ease your concerns and help expand your business.

Environmental Management System Certificate

In monitoring our waste accumulation and sustainability throughout our production process, we would fulfill our environmental management system requirements. Beyond environmental protection, Kemei reduces resource costs and addresses risks during production to boost our performance and productivity.

Source your medical supplies from an industry leader that knows exactly what your market needs.

Join Our Network

    Contact Info

    Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.Address:No. 316 National road, Xinju, Changshan Town, Jinxian County, Nanchang City, 331724 Jiangxi Province, China.

    0086-0791-85352308

    0086-0791-85352311

    sales@jxkmjt.com

    Share on facebook
    Share on twitter
    Share on linkedin

    Copyright © 2022, Kemei. Terms of Service and Privacy Policy. All rights reserved.  Powered by MML.

    0
    several boxes of medical glove

    Product Name

    Lorem ipsum dolor sit

    p03 s02 img3

    Product Name

    Lorem ipsum dolor sit

    p03 s02 img4

    Product Name

    Lorem ipsum dolor sit

    Submit Your Enquiry List to Get a Quote!

      Talk to Specialists