Search Results
Found 5 results
510(k) Data Aggregation
K Number
K021659Device Name
PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)
Manufacturer
Date Cleared
2002-08-12
(84 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
P.T. HEALTHCARE GLOVINDO
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 on the examiners hand on finger to prevent contamination between patient and examiner.
Device Description
Pre-Powdered Latex Examination Gloves With Protein Labeling Claim (180 us
Ask a Question
Ask a specific question about this device
K Number
K010232Device Name
PRE-POWDERED NITRILE EXAMINATION GLOVES
Manufacturer
Date Cleared
2001-09-21
(240 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
P.T. HEALTHCARE GLOVINDO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K010233Device Name
POWDER FREE NITRILE EXAMINATION GLOVES
Manufacturer
Date Cleared
2001-06-22
(149 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
P.T. HEALTHCARE GLOVINDO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K000838Device Name
DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
2000-10-23
(223 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
P.T. HEALTHCARE GLOVINDO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K974853Device Name
LATEX (POWDER FREE) LOW PROTEIN
Manufacturer
Date Cleared
1998-02-09
(42 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
P.T. HEALTHCARE GLOVINDO
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 on the examiner's hand, or finger to prevent contamination between patient and examine.
Device Description
Latex Patient Examination Gloves, Powder-Free (with Protein Content Claim (50hicrogram or less) Labelling of Powder-Free)
Ask a Question
Ask a specific question about this device
Page 1 of 1