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510(k) Data Aggregation

K Number

Device Name

UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED)

Manufacturer

AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD

Date Cleared

1999-02-04

(113 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

UNISEAL Powder Free Latex Examination Gloves (BLUE + GREEN)

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for examination gloves. It does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device. Therefore, I cannot fulfill your request based on the given context.

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