POWDERED LATEX STERILE SURGICAL GLOVES

• K Number: K992219
• Device Name: POWDERED LATEX STERILE SURGICAL GLOVES
• Manufacturer: TG MEDICAL SDN BHD
• Date Cleared: 1999-07-30 ( 29 days)
• Product Code: KGO
• Regulation Number: 878.4460
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The surgical glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between the patient and the surgeon.

Device Description

LATEX SURGICAL GLOVE, POWDERED AND STERILE

AI/ML Overview

This document is a 510(k) clearance letter for Powdered Latex Sterile Surgical Gloves. It does not contain information about acceptance criteria, device performance studies, or clinical trial parameters like sample size, ground truth, or expert qualifications. The letter confirms substantial equivalence to a legally marketed predicate device but does not detail the testing used to establish that equivalence.

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).