Most of the exam gloves available here in the U.S. are manufactured and imported from other countries, such as Malaysia. How can you be sure that you are getting a safe, reliable product? Fortunately, manufacturers, importers and the government are working hard to ensure your safety.
FDA Regulation
Patient examination gloves are a class I medical device and subject to the controls of the FDA. This class of disposable gloves is meant for medical purposes to protect the wearer’s hand and to prevent contamination between the patient and the wearer. The gloves can be made from latex, vinyl or a polymer other than vinyl, such as nitrile or polyurethane.
To meet the FDA requirements for patient examination gloves, the product must meet a number of standards, including the following:
ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D6124 Standard Test Method for Residual Powder on Medical Gloves
ASTM D3578 Standard Test Method for Rubber Examination Gloves
Additionally, there are specific rules for labeling. A powder-free nitrile exam glove that meets FDA requirements will have the words “powder-free nitrile examination glove” on the box. Disposable latex, nitrile or vinyl gloves that do not include the word “examination” on the box are for general purpose use, and are not safe to use in medical, dental or other health care settings.
Ambiguous terms such as “extra-thick” or “super-sensitive” are not allowed on the box because they could be misleading. The term “hypoallergenic” is strongly discouraged, as it cannot be scientifically defined. Only factual and definitive statements are allowed.
Quality System Regulation
Medical glove manufacturers are required to meet the Quality System regulation for medical devices – 21 CFR part 820. This regulation states that “each manufacturer must establish and maintain a quality system that is appropriate for the specific medical device . . . manufactured.”
Malaysian manufacturers run state-of-the-art facilities. There are process controls for every single stage of manufacturing, from compounding , dipping and curing, to drying, powder removal and rinsing. With proper process and quality controls, manufacturers are able to control or eliminate defects in gloves, such as pinholes, as well as control or minimize undesirable chemical residues.
Compliance Inspections
To ensure compliance, the FDA sends auditors to manufacturers, including foreign manufacturing sites, to perform factory inspections. They review the facility, operations, environment and records to determine the level of compliance with the Quality System regulation.
When a glove shipment arrives at a US port, the FDA may hold the shipment and collect a sample of the gloves for testing. If the sample fails, the FDA then detains all lots of the same glove type in the shipment, effectively removing them from the supply chain. They may also hold shipments of gloves that have been misbranded with unsubstantiated claims, or are not labeled properly.
The relationship between glove manufacturers, importers and the FDA helps ensure that the exam gloves you wear will do the job they were meant to do – prevent contamination and keep you safe. So the next time you see “Manufactured in Malaysia” on a box of gloves or product literature, you can be confident you are getting a quality product.
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