NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS

• K Number: K030994
• Device Name: NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS
• Manufacturer: SGMP CO., LTD.
• Date Cleared: 2003-06-12 ( 76 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: K000671
• Predicate For: N/A

Intended Use

A 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

Device Description

NON-STERILE ORANGE COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS AND WITH A PROTEIN LABELING CLAIM (

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the Non-Sterile Orange Colored Powdered Latex Patient Examination Gloves, based on the provided document:

Acceptance Criteria and Device Performance

The device, "Non-Sterile Orange Colored Powdered Latex Patient Examination Gloves with & without Orange/Vanilla Scents and with a Protein Labeling Claim (

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.