Search Results
Found 2 results
510(k) Data Aggregation
K Number
K980729Device Name
NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE)
Manufacturer
Date Cleared
1998-04-02
(36 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. EKA WIRA ASIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand or finger to prevent contamination between patient and examiners.
Device Description
Private Label - Nitrile Examination Gloves Pre-Powdered, Blue and White Color
Ask a Question
Ask a specific question about this device
K Number
K980807Device Name
NITRILE EXAMNATION GLOVES- POWDERFREE (SMALL, MEDIUM AND LARGE)
Manufacturer
Date Cleared
1998-04-02
(36 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. EKA WIRA ASIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purpose that is wom on the examiner's hand or finger to prevent contamination between patient and examiners.
Device Description
Nitrile Patient Examination Gloves - Powder Free Blue and White Color
Ask a Question
Ask a specific question about this device
Page 1 of 1