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Found 2 results

510(k) Data Aggregation

K Number

Device Name

BETEL POWDER FREE LATEX EXAM GLOVES

Manufacturer

BETELCARE SDN BHD

Date Cleared

2000-04-20

(52 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

BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

Manufacturer

BETELCARE SDN BHD

Date Cleared

2000-04-10

(42 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

Ask a Question

Ask a specific question about this device

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