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e-CFR data is current as of January 19, 2021

Title 21Chapter ISubchapter HPart 878Subpart E → §878.4460


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


§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).

[53 FR 23872, June 24, 1988, as amended at 66 FR 46952, Sept. 10, 2001; 81 FR 91730, Dec. 19, 2016]

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