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510(k) Data Aggregation
K Number
K213408Device Name
BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free
Manufacturer
Meditech Gloves SDN BHD
Date Cleared
2022-04-17
(180 days)
Product Code
LZA, LZC, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Meditech Gloves 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.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Powder Free Nitrile Patient Examination Glove, Non-Sterile (Blue) meet all the requirements of ASTM standard D6319-19 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.
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K Number
K210755Device Name
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)
Manufacturer
Meditech Gloves SDN BHD
Date Cleared
2021-05-07
(53 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Meditech Gloves 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 Nitrile Patient Examination Glove, Non-Sterile (Blue) meet all the requirements of ASTM standard D6319-19 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.
Ask a Question
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