21 C.F.R. § 878.4460   Surgeon's glove.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart E—Surgical Devices

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§ 878.4460   Surgeon's glove.

(a) Identification. A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

(b) Classification. Class I (general controls).

[53 FR 23872, June 24, 1988, as amended at 66 FR 46952, Sept. 10, 2001]

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