Title 21: Food and Drugs
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/ PART 878 - GENERAL AND PLASTIC SURGERY DEVICES
/ Subpart E - Surgical Devices / § 878.4460 Non-powdered surgeon's glove.
§ 878.4460 Non-powdered surgeon's glove.
(a) Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
(b) Classification. Class I (general controls).