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Found 2 results

510(k) Data Aggregation

K Number

Device Name

STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE)

Manufacturer

SHANDONG HUAYUE GLOVE CO., LTD.

Date Cleared

2009-05-18

(81 days)

Product Code

Regulation Number

Type

Panel

Hematology (HO)

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

SHANDONG HUAYUE GLOVE CO., LTD.

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

K Number

Device Name

VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED)

Manufacturer

SHANDONG HUAYUE GLOVE CO., LTD.

Date Cleared

2009-05-08

(71 days)

Product Code

Regulation Number

Type

Panel

Hematology (HO)

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

SHANDONG HUAYUE GLOVE CO., LTD.

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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