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510(k) Data Aggregation
K Number
K233182Device Name
Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)
Manufacturer
Date Cleared
2023-12-15
(78 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Zibo Kaiyue Mould Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Powder-Free Nitrile Examination Glove 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
Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)
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