OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM

• K Number: K984066
• Device Name: OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM
• Manufacturer: OMNI INTL., INC.
• Date Cleared: 1999-01-13 ( 58 days)
• Product Code: KGO
• Regulation Number: 878.4460
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A glove to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

OmniGrip Latex Surgeons Gloves, Powder Free WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA to OmniGrace (Thailand) Ltd. regarding their OmniGrip Latex Surgeons Gloves. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter primarily:

• Confirms the FDA's review of the 510(k) notification.
• States that the device is substantially equivalent to legally marketed predicate devices.
• Outlines general regulatory provisions applicable to the device.
• Provides contact information for further regulatory guidance.
• Includes an "Indications For Use" statement for the gloves.

Therefore, I cannot provide the requested information.

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).