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Found 3 results

510(k) Data Aggregation

K Number

Device Name

VINYL EXAMINATION GLOVE, POWDERED

Manufacturer

PINNACLE CO., LTD.

Date Cleared

2008-02-21

(195 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

VINYL EXAMINATION GLOVE POWDER FREE

Manufacturer

PINNACLE CO., LTD.

Date Cleared

2008-02-15

(189 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

SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)

Manufacturer

PINNACLE CO., LTD.

Date Cleared

2008-02-08

(182 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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