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510(k) Data Aggregation
K Number
K221143Device Name
Nitrile Exam Gloves (Blue, Black)
Manufacturer
Date Cleared
2022-08-25
(127 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hebei Astro Medical Supply Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Nitrile Exam Gloves (Blue, Black) is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.
Device Description
The proposed device is a power free medical glove. The device is provided in blue and black. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in six sizes, which are XS, S, M, L, XL, XXL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.
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K Number
K213019Device Name
Vinyl Exam Gloves
Manufacturer
Date Cleared
2022-01-05
(107 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hebei Astro Medical Supply Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Vinyl Exam Gloves 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
The proposed device is a powder free medical glove. The device is available in transparent. The device meets the requirements of ASTM D5250-19: Standard specification for Poly (vinyl chloride) Gloves for Medical Application. The proposed gloves are available in five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.
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