NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT

• K Number: K093496
• Device Name: NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT
• Manufacturer: OON CORP. RESOURCES
• Date Cleared: 2010-02-03 ( 85 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVE WITH AND/OR WITHOUT STRAWBERRY SCENT, AND WITH PROTEIN LABELING CLAIM (50 micrograms or less) 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, POWDER-FREE, PINK LATEX EXAMINATION GLOVES, WITH AND/OR WITHOUT STRAWBERRY SCENT, AND WITH PROTEIN CONTENT LABELING CLAIM (50 Micrograms or Less)

AI/ML Overview

This document is a 510(k) premarket notification acceptance letter for latex examination gloves, not a study describing the acceptance criteria and performance of a device. Therefore, I cannot extract the requested information like sample sizes, expert qualifications, or details about comparative effectiveness studies.

The document indicates that the device is "substantially equivalent" to legally marketed predicate devices, meaning it does not require a new premarket approval application (PMA). The notification simply states the "Indications for Use" for the gloves:

Indications for Use:
"A NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVE WITH AND/OR WITHOUT STRAWBERRY SCENT, AND WITH PROTEIN LABELING CLAIM (50 micrograms or less) 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."

This type of document does not contain the specific performance metrics or study details you are asking for. It's an administrative approval based on demonstrating equivalence, not a detailed report of a study validating acceptance criteria.

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.