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510(k) Data Aggregation
K Number
K220088Device Name
Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Manufacturer
Professional Latex Sdn Bhd
Date Cleared
2023-03-30
(443 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Professional Latex Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Powder Free Nitrile Examination Gloves, Non-Sterile, and tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a patient medical exam gloves which is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM-D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Powder Free Nitrile Examination Gloves, Non-Sterile, and Tested for Juse with Chemotherapy Drugs and Fentanyl Citrate meets all the requirements of ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the-counter single use. It is an ambidextrous, light blue colour device with wide range of sizes, i.e (XS, S, M, L and XL). It is designated for single use only.
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K Number
K173053Device Name
POWDER FREE LATEX EXAMINATION GLOVE
Manufacturer
Professional Latex Sdn Bhd
Date Cleared
2018-06-06
(251 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Professional Latex Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Device Description
Powder Free Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
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K Number
K171667Device Name
Powder Free Nitrile Examination Glove
Manufacturer
Professional Latex Sdn Bhd
Date Cleared
2017-09-08
(95 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Professional Latex Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Device Description
Non-Sterile, Powder Free Nitrile Examination Gloves - Blue meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for overthe counter single use.
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