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510(k) Data Aggregation
K Number
K213048Device Name
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
Manufacturer
Date Cleared
2021-12-18
(87 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Huayuan Medical Technology(Shangqiu) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination 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.
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, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in six sizes: XS, S, M, L, XL, XXL. The subject device is non-sterile.
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K Number
K211012Device Name
Nitrile Patient Examination Gloves
Manufacturer
Date Cleared
2021-07-23
(109 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Huayuan Medical Technology(Shangqiu) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Device Description
The subject device is powder free nitrile examination gloves. The subject device is cobalt blue. The subject device is non-sterile.
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K Number
K211028Device Name
Nitrile Patient Examination Gloves
Manufacturer
Date Cleared
2021-06-04
(59 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Huayuan Medical Technology(Shangqiu) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger 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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