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510(k) Data Aggregation

K Number

Device Name

POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR

Manufacturer

HWA TEH INDUSTRIAL SDN. BHD.

Date Cleared

2001-05-11

(56 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR

Manufacturer

PAMITEX INDUSTRIES SDN BHD

Date Cleared

2000-06-30

(29 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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Ask a specific question about this device

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