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510(k) Data Aggregation
K Number
K182117Device Name
Vinyl Patient Examination Gloves
Date Cleared
2018-10-06
(61 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Jiangxi Zhonghong Pulin Medical Products Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiners hands to prevent contamination between patient and examiner.
Device Description
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTMD5151, and ASTMD5250. The proposed device is non-sterile.
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