Search Results
Found 3 results
510(k) Data Aggregation
K Number
K103619Device Name
SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED)
Manufacturer
Date Cleared
2011-08-10
(243 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANDONG BLUE SAIL INNOVATION CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Synthetic Vinyl Examination Glove Powder Free coated with Allogel(Green/Blue/White/Magenta/Clear (non colored)) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Synthetic Vinyl Examination Glove Powder Free Coated With Allogel (Green/Blue/White/Magenta/Clear (non colored))
Ask a Question
Ask a specific question about this device
K Number
K102161Device Name
BLUE SAIL INNOVATION
Manufacturer
Date Cleared
2010-10-08
(67 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANDONG BLUE SAIL INNOVATION CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Vinyl examination glove, Powder Free, Clear(Non-Colored) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder-Free, Vinyl Examination Gloves, Clear (Non-Colored)
Ask a Question
Ask a specific question about this device
K Number
K102160Device Name
STRETCH VINYL EXAMINATION GLOVE POWDER FREE
Manufacturer
Date Cleared
2010-10-04
(63 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANDONG BLUE SAIL INNOVATION CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Stretch Vinyl Examination Glove Colored(Yellow/White) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder-Free, Stretch Vinyl Examination Gloves, (Yellow/White)
Ask a Question
Ask a specific question about this device
Page 1 of 1