Search Results
Found 10 results
510(k) Data Aggregation
K Number
K122727Device Name
BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE
Manufacturer
NORTHSTAR HEALTHCARE HOLDINGS
Date Cleared
2013-02-22
(170 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
NORTHSTAR HEALTHCARE HOLDINGS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 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 examiner.
Device Description
Sterile, powder free, examination gloves made of nitrile. The gloves are provided in sizes small, medium, and large. Sterile gloves are provided in dispenser boxes.
Ask a Question
K Number
K122788Device Name
TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O
Manufacturer
NORTHSTAR HEALTHCARE HOLDINGS
Date Cleared
2013-01-17
(128 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
NORTHSTAR HEALTHCARE HOLDINGS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The examination glove is a disposuble device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Textured, White, Latex, Sterile Powder Free Examination Gloves with Protein labeling Claim (50µg/dm² or Less of Water Soluble Protein)
Ask a Question
K Number
K123026Device Name
TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO
Manufacturer
NORTHSTAR HEALTHCARE HOLDINGS
Date Cleared
2012-11-16
(49 days)
Product Code
LYY, REG
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
NORTHSTAR HEALTHCARE HOLDINGS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 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 examiner.
Device Description
Powder free, examination gloves made of latex and colored blue. The gloves are provided in sizes small, medium, large and extra large.
Ask a Question
K Number
K122998Device Name
BLUE POWDERED NITRILE EXAMINATION GLOVE
Manufacturer
NORTHSTAR HEALTHCARE HOLDINGS
Date Cleared
2012-11-06
(40 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
NORTHSTAR HEALTHCARE HOLDINGS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 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 examiner.
Device Description
Nitrile Powdered patient examination glove
Ask a Question
K Number
K121926Device Name
BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM
Manufacturer
NORTHSTAR HEALTHCARE HOLDINGS
Date Cleared
2012-09-20
(80 days)
Product Code
LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
NORTHSTAR HEALTHCARE HOLDINGS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 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 examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation of Chemotherapy Drugs.
Device Description
Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50µg/dm² Or Less Of Water Soluble Protein).
Ask a Question
K Number
K121947Device Name
ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES
Manufacturer
NORTHSTAR HEALTHCARE HOLDINGS
Date Cleared
2012-09-10
(69 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
NORTHSTAR HEALTHCARE HOLDINGS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 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 examiner.
Device Description
Powder free blue nitrile patient exam glove, meets all the requirements of ASTM standard D6319, except for sterility requirements. Non-sterile, powder free, examination gloves made of nitrile and colored blue. The textured gloves are provided in sizes extra small, small, medium, large and extra large. Non-sterile gloves are provided in dispenser boxes.
Ask a Question
K Number
K121529Device Name
BLACK NITRILE POWDER-FREE EXAMINATION GLOVES
Manufacturer
NORTHSTAR HEALTHCARE HOLDINGS
Date Cleared
2012-07-12
(49 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
NORTHSTAR HEALTHCARE HOLDINGS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 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 examiner.
Device Description
Powder free black nitrile patient examination glove, that meets all the requirements of ASTM standard D6319, except for sterility requirements.
Ask a Question
K Number
K121464Device Name
BLUE POWER FREE NITRILE EXAMINATION GLOVE
Manufacturer
NORTHSTAR HEALTHCARE HOLDINGS
Date Cleared
2012-07-05
(49 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
NORTHSTAR HEALTHCARE HOLDINGS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 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 examiner.
Device Description
Powder free blue nitrile patient examination glove, tested for use with Chemotherapy drugs, that meets all the requirements of ASTM standard D6319, except for sterility requirements.
Ask a Question
K Number
K121506Device Name
UTB BLUE POWDER FREE NITRILE
Manufacturer
NORTHSTAR HEALTHCARE HOLDINGS
Date Cleared
2012-07-03
(43 days)
Product Code
LZA, CLA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
NORTHSTAR HEALTHCARE HOLDINGS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 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 examiner.
Device Description
Powder free blue nitrile patient examination glove, that meets all the requirements of ASTM standard D6319, except for sterility requirements.
Ask a Question
K Number
K112988Device Name
POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE
Manufacturer
NORTHSTAR HEALTHCARE HOLDINGS LIMITED
Date Cleared
2011-11-09
(34 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
NORTHSTAR HEALTHCARE HOLDINGS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 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 examiner.
Device Description
Powder Free Latex Patient Exam Glove, Smooth and Textured Natural Color (Off White) with Protein Labeling Claim (50 µg/dm² or less of water soluble protein)
Ask a Question
Page 1 of 1