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510(k) Data Aggregation
K Number
K210522Device Name
Disposable Vinyl Examination Gloves
Date Cleared
2021-06-10
(107 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**Shandong Shengshixincheng Medical Science **& Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Vinyl Examination Gloves are disposable devices intended for medical purposes that are 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 devices have two color: blue and clear. 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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K Number
K210520Device Name
Disposable Synthetic Examination Gloves
Date Cleared
2021-05-26
(92 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**Shandong Shengshixincheng Medical Science **& Technology Co
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 to prevent contamination between patient and examiner.
Device Description
The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. 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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