PRE-POWDERED LATEX SURGEON'S GLOVES

• K Number: K023515
• Device Name: PRE-POWDERED LATEX SURGEON'S GLOVES
• Manufacturer: SANREA HEALTHCARE PRIVATE LIMITED
• Date Cleared: 2003-01-16 ( 87 days)
• Product Code: KGO
• Regulation Number: 878.4460
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination

Device Description

pre-POWDERED LATEX SURGEON'S GLOVES

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for Sanrea Healthcare Private Limited's "Pre-Powdered Latex Surgeon's Gloves." It does not contain information on acceptance criteria, study data, or AI-related performance. Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. This document is solely an FDA clearance for marketing the device based on substantial equivalence to a predicate device.

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).