Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove

• K Number: K183536
• Device Name: Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
• Manufacturer: Hartalega Ngc Sdn. Bhd.
• Date Cleared: 2019-08-16 ( 240 days)
• Product Code: KGO
• Regulation Number: 878.4460
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Latex Powder Free Surgical Glove With Protein Labelling Claim of 50 Microgram or Less per Gram of Glove is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination.

Device Description

Latex Powder Free Surgical Glove With Protein Labelling Claim of 50 Microgram or Less per Gram of Glove is made of natural rubber.

AI/ML Overview

This document is a 510(k) clearance letter for a "Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove." It does not contain information about acceptance criteria, device performance, or study details as would be found for a diagnostic or AI-based medical device.

Therefore, I cannot provide the requested information. This document is a regulatory clearance for a physical medical product, not a software or AI-driven device that would typically undergo the kind of performance studies you've outlined.

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).