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510(k) Data Aggregation
K Number
K202010Device Name
Disposable Vinyl Glove
Manufacturer
Date Cleared
2020-10-16
(87 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Better Health Medical Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Vinyl Glove is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Device Description
The subject device is powder free vinyl patient examination gloves. The subject device is clear, non-colored. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
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