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510(k) Data Aggregation

K Number

Device Name

NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES

Manufacturer

TERANG NUSA SDN BHD

Date Cleared

2009-01-27

(76 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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