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Title 21 Part 880 → Subpart G → §880.6250

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart G → §880.6250

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart G → §880.6250

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

Title 21Chapter ISubchapter HPart 880Subpart G → §880.6250


Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart G—General Hospital and Personal Use Miscellaneous Devices


§880.6250   Non-powdered patient examination glove.

(a) Identification. A non-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 non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 1604, Jan. 13, 1989; 66 FR 46952, Sept. 10, 2001; 81 FR 91730, Dec. 19, 2016; 84 FR 71815, Dec. 30, 2019]