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Found 2 results

510(k) Data Aggregation

K Number

Device Name

POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

Manufacturer

BIOGRAFIK (MALAYSIA) SDN BHD

Date Cleared

1999-12-29

(72 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

BIOGRAFIK (MALAYSIA) SDN BHD

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

A patient examination glove is worn on the hand of healthcare and similar personnel to prevent containination between healthcare personnel and the patient

Device Description

Powder Free Latex Examination Gloves, Non-Sterile, Polymer Coated WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

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K Number

Device Name

BG PATIENT EXAMINATION GLOVES, NON-STERILE

Manufacturer

BIOGRAFIK (MALAYSIA) SDN BHD

Date Cleared

1996-07-25

(90 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

BIOGRAFIK (MALAYSIA) SDN BHD

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

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