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K Number
K991940
Device Name
BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)
Manufacturer
BRIGHTWAY HOLDINGS SDN. BHD.
Date Cleared
1999-07-12

(33 days)

Product Code
KGO
Regulation Number
878.4460
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

BRIGHTWAY™ Brand Nitrile Surgical Gloves - Sterile (Powdered) is intended to be worn by a ulsposable glove made or by a protect a surgical wound from contamination.

Device Description

BRIGHTWAY™ Brand Nitrile Surgical Gloves - Sterile (Powdered)

AI/ML Overview

This looks like a 510(k) clearance letter for Nitrile Surgical Gloves. The provided text does not contain information about acceptance criteria, device performance from a study, sample sizes, expert qualifications, or ground truth establishment relevant to the request. This document is a regulatory approval letter, not a study report.

Therefore, I cannot answer the questions based on the provided input.

§ 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).