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| [Code of Federal Regulations] |
| [Title 21, Volume 8] |
| [CITE: 21CFR895] |
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
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Subpart B - Listing of Banned Devices
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Sec. 895.101 Prosthetic hair fibers.
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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]
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Sec. 895.102 Powdered surgeon's glove.
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(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]
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Sec. 895.103 Powdered patient examination glove.
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(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]
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Sec. 895.104 Absorbable powder for lubricating a surgeon's glove.
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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]
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Sec. 895.105 Electrical stimulation devices for self-injurious or aggressive behavior.
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Electrical stimulation devices for self-injurious or aggressive behavior are aversive conditioning devices that apply a noxious electrical stimulus to a person's skin to reduce or cease self-injurious or aggressive behavior.
[85 FR 13354, Mar. 6, 2020]
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Authority: 21 U.S.C. 352, 360f, 360h, 360i, 371.
Source: 44 FR 29221, May 18, 1979, unless otherwise noted.
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