Search Results
Found 2 results
510(k) Data Aggregation
K Number
K980605Device Name
LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE)
Manufacturer
Date Cleared
1998-04-14
(56 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SARANA INDOPROTEX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A pation cxamination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Latex Patient Examination Gloves (Powder-Trade Name: Free) with Protein Content Labeling Claim (50 micrograms or less)
Ask a Question
Ask a specific question about this device
K Number
K970773Device Name
POWDER-FREE EXAM GLOVES
Manufacturer
Date Cleared
1997-12-04
(275 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. SARANA INDOPROTEX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Patient examination gloves are "disposable medical devices intended for medical purposes that are worn on the examiner's hand to help prevent contamination between patient and examiner".
Device Description
Latex Patient examination gloves, Powder Free
Ask a Question
Ask a specific question about this device
Page 1 of 1