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Title 21

Displaying title 21, up to date as of 9/23/2021. Title 21 was last amended 9/21/2021.

Title 21

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§ 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]