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510(k) Data Aggregation
K Number
K212834Device Name
Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)
Manufacturer
Date Cleared
2021-12-30
(114 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Siyang Threeguard Medical Supplies Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
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 qloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in five sizes: extra-small, small, medium, large, and extra-large.
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K Number
K211131Device Name
Disposable Nitrile Medical Examination Glove
Manufacturer
Date Cleared
2021-07-29
(104 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Siyang Threeguard Medical Supplies Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Nitrile Medical Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
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