Search Results
Found 14 results
510(k) Data Aggregation
K Number
K102096Device Name
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Manufacturer
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
Date Cleared
2010-10-04
(69 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
Chemotherapy Drug | Average BDT
--------------------|-------------
Fluorouracil | >240 min.
Etoposide (Toposar) | >240 min.
Cyclophosphamide (Cytoxan) | >240 min.
Carmustine | 2.03 min.
Thiotepa | 25.23 min.
Paclitaxel (Taxol) | >240 min.
Doxorubicin Hydrochloride | >240 min.
Dacarbazine (DTIC) | >240 min.
Cisplatin | >240 min.
Please note that Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.
Ask a Question
K Number
K052877Device Name
POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE
Manufacturer
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
Date Cleared
2005-11-08
(27 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Nitrile Patient Examination Glove, 80 LZA, and meets all requirements of ASTM standard D-6319-00€3
Ask a Question
K Number
K042226Device Name
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY
Manufacturer
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
Date Cleared
2004-09-30
(44 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 examiner.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00aE3.
Ask a Question
K Number
K033777Device Name
ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
Manufacturer
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
Date Cleared
2004-02-05
(63 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
Ultrasense AF Blue Power-free Nitrile Examination Gloves
Ask a Question
K Number
K023826Device Name
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR
Manufacturer
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
Date Cleared
2003-01-24
(67 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Device Description
Syntex Powder-Free Latex Examination Gloves - Blue Color. A powder-free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder.
Ask a Question
K Number
K022784Device Name
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR
Manufacturer
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
Date Cleared
2002-11-13
(83 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder-Free Nitrile Examination Glove -- Purple Color
Ask a Question
K Number
K022088Device Name
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE
Manufacturer
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
Date Cleared
2002-09-03
(68 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Device Description
Syntex Powder-Free Latex Examination Glove
Ask a Question
K Number
K022090Device Name
SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE
Manufacturer
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
Date Cleared
2002-09-03
(68 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Device Description
Pre-Powdered Nitirile Examination Glove
Ask a Question
K Number
K022092Device Name
SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE
Manufacturer
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
Date Cleared
2002-09-03
(68 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Syntex Pre-Powdered Latex Examination Glove
Ask a Question
K Number
K022146Device Name
SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE
Manufacturer
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
Date Cleared
2002-09-03
(63 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SYNTEX HEALTHCARE PRODUCTS CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder-Free Polymer-Coated Latex Examination Glove
Ask a Question
Page 1 of 2