Search Results
Found 1 results
510(k) Data Aggregation
K Number
K143277Device Name
Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile),
Manufacturer
Date Cleared
2015-07-29
(257 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Lifestyle Safety Products (Hui Zhou) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Cream Stretch Vinyl Patient Examination Glove (Non-Sterile) and White Vinyl Patient Examination Glove (Non-Sterile) are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. They are both sold as non-sterile.
Device Description
Cream Stretch Vinyl Patient Examination Glove (Non-Sterile) and White Vinyl Patient Examination Glove (Non-Sterile) are patient examination gloves available in S, M, L, XL. They are provided non-sterile and meet the entire requirement of ASTM standard D 5250-06, except for sterility requirements.
Ask a Question
Ask a specific question about this device
Page 1 of 1