21 CFR 880.6250
§ 880.6250 Non-powdered patient examination glove.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 880.6250, § 880.6250 Non-powdered patient examination glove, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90580
- Permanent ID
ys:prov:90580@1- SHA-256
7a71ae77cfd5971520a82f49ef771ef15db50ea55b2c96a8fbd5aac5ca51c0ce
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.