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510(k) Data Aggregation
K Number
K230777Device Name
Patient Examination Gloves
Manufacturer
Date Cleared
2023-10-06
(199 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
3A Glove Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Patient Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
Device Description
The proposed device is a nitrile patient examination glove. The design of proposed device addresses the standard specification requirements of ASTM D6319-19. The proposed device is non-sterile and powder free, with fern green, midnight black and sky blue three colors.
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K Number
K230847Device Name
Chemotherapy Gloves
Manufacturer
Date Cleared
2023-09-29
(185 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
3A Glove Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Chemotherapy Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. The proposed device is non-sterile, with fern green, midnight black and sky blue three colors.
Device Description
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large and with fern green, midnight black and sky blue three colors for options to each sizes.
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