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510(k) Data Aggregation
K Number
K213662Device Name
Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs)
Manufacturer
Date Cleared
2022-03-28
(126 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Taishan Weibang Medical Equipment Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove 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 four sizes: small, medium, large, and extra-large. The subject device is non-sterile.
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