STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE)

• K Number: K090520
• Device Name: STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE)
• Manufacturer: SHANDONG HUAYUE GLOVE CO., LTD.
• Date Cleared: 2009-05-18 ( 81 days)
• Product Code: LYZ
• Regulation Number: 880.6250

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 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.

Summary

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