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Found 2 results

510(k) Data Aggregation

K Number

Device Name

CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G

Manufacturer

CROCKER INDUSTRIAL RESOURCES SDN. BHD.

Date Cleared

1998-05-18

(81 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

CROCKER INDUSTRIAL RESOURCES SDN. BHD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

CIR latex examination glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment.

Device Description

CIR Latex Gloves, Non-Sterile, Powdered [Latex Examination Gloves (Powdered, Non-Sterile) with Protein Labeling Claim of ≤ 200 µg/g]

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K Number

Device Name

LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED)

Manufacturer

CROCKER INDUSTRIAL RESOURCES SDN. BHD.

Date Cleared

1997-03-19

(386 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

CROCKER INDUSTRIAL RESOURCES SDN. BHD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

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