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510(k) Data Aggregation
K Number
K222103Device Name
Nitrile Patient Examination Gloves, Powder Free, Pink Color
Manufacturer
Date Cleared
2023-08-24
(402 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Shandong YINGHNG Medical Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
Device Description
The subject device in this 510(k) Notification is Nitrile Patient Examination Gloves, Powder Free, Pink Color. The subject device is a patient examination glove made from nitrile compound, pink color, powder free and non-sterile (Per 21 CFR 880.6250, class I). These gloves are pink in color and are powder free. The gloves are ambidextrous single use disposable devices that come in six sizes (XS, S, M, L, XL and XXL).
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