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U.S. Department of Health and Human Services

Medical Devices

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2. Glove Lubricants

ABSORBABLE DUSTING POWDER

COAGULANTS AND RELEASE AGENTS

ABSORBABLE DUSTING POWDER

Donning lubricants such as cornstarch and silicone may make it easier to put on medical gloves. Powdered lubricants are also called donning powders or dusting powders. Powder from medical gloves directly contacts wounds, body cavities, and skin and can contaminate both the patient’s and the user’s environment. FDA believes it is important to minimize the amount of powder on finished gloves. We recommend that you establish a specification for the amount of powder on a glove and a procedure to verify that powder levels on finished gloves meet that specification.

A small amount of silicone or other lubricant is also used on some powder-free gloves to aid in donning. If used, the lubricants should be on the finished gloves when you conduct biocompatibility tests. You should identify the complete chemical characterization/chemical formulation of the lubricant in the 510(k) submission.

Examination Gloves. Cornstarch that meets the specification for absorbable donning or dusting powder in the United States Pharmacopeia (U.S.P.) is a commonly used lubricant for examination gloves. Any powder used for lubricating examination gloves should meet the U.S.P. monograph for absorbable dusting powder or be equivalent in terms of safety and effectiveness. The 510(k) submission should state the type, specifications, and source of powder or other donning lubricant used on the gloves. You should not use talc, cotton flock, and other non-absorbable materials as a lubricating, dusting, or donning powder. Recognized consensus standards specify that the inside and outside surface of medical gloves be free of talc. Lycopodium (club moss spores) and ground pine pollen are toxic. You should not use them as powder on or in medical gloves.

Surgeon’s Gloves. Absorbable dusting powder for lubricating a surgeon’s glove is a transitional device (a device formerly regulated as a new drug before l976). FDA classifies it as a class III medical device under 21 CFR 878.4480 (product code KGP). Absorbable dusting powder for lubricating a surgeon’s glove requires an approved Premarket Approval Application (PMA) or, if marketed prior to May 28, l976, a New Drug Application (NDA). You may use only absorbable dusting powders manufactured under an approved PMA or NDA on powdered surgeon’s gloves.

A current list of approved NDAs or PMAs for Surgical Dusting Powder is available through the PMA database on the FDA website. Place KGP in the Product Code box and click on Search.

PMA database: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm

Guidance on the content and format for a PMA for Absorbable Powder for Lubricating a Surgeon’s Glove is available at:

Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon’s Glove

Device Advice PMA

COAGULANTS AND RELEASE AGENTS

In order to have uniform distribution of the latex mix on the mold, commonly called a “former,” the mold is first dipped in a coagulant solution usually containing a calcium salt in water. In addition, the coagulant solution sometimes contains a lubrication agent to facilitate stripping (removing) the gloves from the molds at the end of the production line. A small amount of the coagulant and release agent remains on the "inside" surface of the glove. In some processes, washing removes most of the mold release agent from the surface of the glove. If these manufacturing material residues can adversely affect the safety or effectiveness of the gloves, you must establish and maintain procedures for the use and removal of the manufacturing material to ensure that it is removed or limited to an amount that does not adversely affect the gloves's quality (21 CFR 820.70(h).