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510(k) Data Aggregation
K Number
K211103Device Name
Powder Free Vinyl Examination Gloves
Manufacturer
Date Cleared
2021-11-04
(205 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Shengda Medical Applications Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The powder free vinyl patient examination glove is a clear, non-colored, disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is sold as non sterile.
Device Description
The powder free vinyl patient examination glove is a clear, non-colored, disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is sold as non sterile.
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