Work Item
ASTM WK85889

New Specification for Medical Gloves made from a blend of materials.

1. Scope

Research medical gloves currently on the market which include a blend of materials. Determine what changes to existing standards must be made to apply to these products.

Keywords

Surgical Gloves; Examination Gloves; Chemotherapy Gloves; Radiation Attenuating Gloves

Rationale

There have been several reported incidents of medical gloves on the market which are not made of the material advertised on the product, or are made of a blend of materials with the claimed material a small percentage of the blend. These products are then tested to the requirements of the claimed material rather than the actual material, allowing low quality products to claim compliance with ASTM standards. After a lengthy discussion a consensus was reached about two issues. First, that the current standards are written to address gloves made from a single ingredient and are not clear about what requirements gloves made from blends need to meet. Second, that mislabeling the ingredients is a serious problem and that the standards should require that the materials used are properly labeled, including listing all ingredients in a blend and the ratio of the blend. There was not a consensus on what requirements blends should meet, and it was decided to create a new work item to research fillers and blends currently on the market and how the standards should address these blends.

The title and scope are in draft form and are under development within this ASTM Committee.

Details

Developed by Subcommittee: D11.40

Committee: D11

Staff Manager: Melissa Marcinowski

Work Item Status

Date Initiated: 04-07-2023

Technical Contact: William Hooper

Item: 000

Ballot:

Status: