Is the FDA Banning Powdered Gloves? Cleanroom World

Is the FDA Banning Powdered Gloves?

When you work in an industry where fingerprints or a flake of dry skin could contaminate a project costing millions of dollars, wearing protective gloves becomes critically important. Laboratory workers know that latex, cotton, polyurethane or nitrile gloves are a necessary part of their work apparel. But, does the FDA regulate the type of gloves used in laboratory environments?

The U.S. Food and Drug Administration (FDA) publishes required and recommended standards, including the need for gloves, for manufacturers of pharmaceuticals, and medical devices who utilize cleanrooms. These parameters are based on the current good manufacturing practice, or CGMP, regulations.

What’s Wrong With Using Powdered Gloves?

As of March 2016, The FDA is proposing to ban powdered gloves in medical applications because they pose a substantial health risk to users & patients, including respiratory allergic reactions, severe airway inflammation, and in surgical applications, wound inflammation and the formation of bands of fibrous scar tissue between internal organs and tissues.

The gloves included in the proposed ban include powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating surgeon’s gloves. Non-powdered surgeon gloves and patient examination gloves are not part of the proposed ban.

Traditionally, both powdered and non-powdered gloves are used in laboratory settings. For some lab settings, powdered gloves have been considered adequate. However, for cleanrooms where particulate matter can cause harm, powdered gloves should never be used. At the time of publication, the ban has not been approved.

What Gloves Should Be Worn?

When selecting gloves for employees to wear in cleanrooms, they need to meet the following criteria:
• powder-free to avoid contamination
• packaged in plastic bags (cardboard can leave particles on the gloves)
• durable and not likely to tear
• easy to put on and remove
• non-porous (so materials such as powders or liquids aren’t transferred)
• solvent-resistant (if working with solvents)

In some cleanroom facilities, skin lotions or lanolin based soaps may be used to help reduce dry skin and skin flaking. These products should be applied in a transition area before entering the cleanroom.

Consult your business operations manual to determine what type of gloves have are approved for your facility. Cleanroom World offers a variety of powdered and non-powdered gloves in various sizes, colors, and materials to meet your needs.