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Electronic Code of Federal Regulations

e-CFR data is current as of March 26, 2020

Title 21Chapter ISubchapter HPart 895 → Subpart B


Title 21: Food and Drugs
PART 895—BANNED DEVICES


Subpart B—Listing of Banned Devices


Contents
§895.101   Prosthetic hair fibers.
§895.102   Powdered surgeon's glove.
§895.103   Powdered patient examination glove.
§895.104   Absorbable powder for lubricating a surgeon's glove.
§895.105   xxx

§895.101   Prosthetic hair fibers.

Prosthetic hair fibers are devices intended for implantation into the human scalp to simulate natural hair or conceal baldness. Prosthetic hair fibers may consist of various materials; for example, synthetic fibers, such as modacrylic, polyacrylic, and polyester; and natural fibers, such as processed human hair. Excluded from the banned device are natural hair transplants, in which a person's hair and its surrounding tissue are surgically removed from one location on the person's scalp and then grafted onto another area of the person's scalp.

[48 FR 25136, June 3, 1983]

§895.102   Powdered surgeon's glove.

(a) Identification. A 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 powdered surgeon's glove incorporates powder for purposes other than manufacturing.

(b) [Reserved]

[81 FR 91731, Dec. 19, 2016]

§895.103   Powdered patient examination glove.

(a) Identification. A powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A powdered patient examination glove incorporates powder for purposes other than manufacturing.

(b) [Reserved]

[81 FR 91731, Dec. 19, 2016]

§895.104   Absorbable powder for lubricating a surgeon's glove.

Absorbable powder for lubricating a surgeon's glove is a powder made from cornstarch that meets the specifications for absorbable powder in the United States Pharmacopeia (U.S.P.) and that is intended to be used to lubricate the surgeon's hand before putting on a surgeon's glove. The device is absorbable through biological degradation.

[81 FR 91731, Dec. 19, 2016]

§895.105   xxx

Link to an amendment published at 85 FR 13354, Mar. 6, 2020.

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