Quality Standards for Exam Gloves

Selling gloves that are considered Exam grade gloves in the United States requires approval from the Food & Drug Administration. There are four primary organizations that dictate the quality standards required in the United States for Exam Gloves. Each organization has a different role in the overall certification:

1. TUV Certification
2. ISO authorization
3. ANSI approval
4. ASTM tests completed

In order for exam grade gloves to be sold in the United States, 510(k) status must be given by the Center for Devices & Radiological Health (CDRH). To receive 510(k) status, the guidelines set by each organization must be followed.

1. The Technical Inspection Association (TUV) is a leading technical service company active in the Industry, Product and Transport Sectors. Its range of services encompasses consultancy, inspections, tests and expert opinions as well as certification and training. In order for a manufacturer to receive ISO status, they must receive certification from TUV.

2. The International Organization Standardization (ISO) is the world’s largest developer and publisher of international standards. 163 countries are involved in this non-governmental organization that forms a bridge between the public and private sectors. When ISO standards are being met by a manufacturer, they use accredited agencies, such as ANSI, to ensure their standards are being followed.

3. The American National Standards Institute (ANSI) is the authority of the US standards and conformity assessment system. They oversee the creation, distribution and use of guidelines that impact businesses in nearly ever sector. They are also involved in accrediting programs that assess conformance to standards such as the ISO 9000 systems. This pertains directly to organizations such as the ASTM.

4. The American Society for Testing & Materials (ASTM) is one of the largest voluntary standards development organizations in the world. They are considered a trusted source for technical standards in materials, products, systems and services. ASTM is responsible for setting the standards in the tests that are required to meet FDA guidelines. The following tests were created by the ASTM to ensure exam grade gloves meet the standards required by the FDA:

D5151 – Water Test

This test is used to detect holes that allow water leakage. Each glove is filled with water to determine if any pinholes exist. Any holes in the gloves count as a defect. The score is then calculated by the number of defective gloves for every 100 tested. The FDA requires an AQL (Acceptable Quality Level) of 2.5 or lower for exam gloves, meaning there has to be 2.5 gloves or less that are defective.

D5712 – Protein Level Test

This test is used to determine the amount of total extractable protein in latex gloves. All latex gloves cannot contain more than 50 micrograms of protein per gram of glove.

D6124 – Residual Powder Test

This test is used to determine the average powder mass found on a sample of gloves. The amount of powder allowed on powdered gloves is 120mg. Powder free gloves may only contain a maximum of 2mg per glove.

D1671 – Blood-Borne Pathogen Test

This test method is used to measure the resistance of penetration by blood-borne pathogens. Phi-X174, one of the smallest measurable viruses in the world, is used to test the glove’s ability to act as a barrier. If the glove acts as a good barrier to the Phi-X174 virus, it is considered a good barrier against larger viruses such as Hepatitis B, C and the AIDS virus.

D412 – Tensile Test

This test is used to measure the tensile strength and percent elongation of gloves when stretched to both their yield and breaking points. The strength is measured in MPa (megapascals) while the elongation percentage is based on the glove’s ability to elongate during tension.

D3578 – Medical Grade Latex

This standard is used to specify the dimensions, tolerances and physical requirements for latex exam gloves. Latex exam gloves must have an AQL of 2.5, tensile strength of at least 18 MPa and a minimum of 700% elongation.

D6319 – Medical Grade Nitrile

This standard is used to specify the dimensions, tolerances and physical requirements for nitrile exam gloves. Nitrile exam gloves must have an AQL of 2.5, tensile strength of at least 14 MPa and a minimum of 500% elongation.

D5250 – Medical Grade Vinyl

This standard is used to specify the dimensions, tolerances and physical requirements for vinyl exam gloves. Vinyl exam gloves must have an AQL of 2.5, tensile strength of at least 11 MPa and a minimum of 300% elongation.

Terms:

510(k) – FDA Premarket Notification

Certification from the FDA approving products sold in the US that are intended for use in a medical capacity.

AQL – Acceptable Quality Level

The minimum manufacturing requirement needed before products are approved.

MPa – Megapascals

Unit of measurement used to determine the strength of a material in a tensile strength test.

References:

1. http://www.tuvamerica.com
2. http://www.iso.org
3. http://www.ansi.org
4. http://www.astm.org
5. http://www.fda.gov/MedicalDevices/default.htm
6. http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/d