Search Results
Found 30 results
510(k) Data Aggregation
K Number
K121549Device Name
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE
Manufacturer
SIAM SEMPERMED CORP. LTD.
Date Cleared
2012-12-27
(216 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SIAM SEMPERMED CORP. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Non-sterile, Powder-free Nitrile Examination Glove with Polymer coating, Aloe and Vitamin E. Blue.
Ask a Question
K Number
K122363Device Name
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Manufacturer
SIAM SEMPERMED CORP. LTD.
Date Cleared
2012-09-10
(35 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SIAM SEMPERMED CORP. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free 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
Non sterile, Powder free Nitrile Examination Glove, Blue.
Ask a Question
K Number
K100907Device Name
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL
Manufacturer
SIAM SEMPERMED CORP. LTD.
Date Cleared
2010-07-09
(99 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SIAM SEMPERMED CORP. 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
Non-Sterile, powder-free latex examination gloves and protein claim (50 micrograms or less).
Ask a Question
K Number
K082957Device Name
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS
Manufacturer
SIAM SEMPERMED CORP. LTD.
Date Cleared
2009-05-29
(238 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SIAM SEMPERMED CORP. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Based upon 21 CFR Part 880.6250; "Patient examination glove" . A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner
Device Description
Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coated, Tested for use with chemotherapy drugs.
Ask a Question
K Number
K083755Device Name
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS
Manufacturer
SIAM SEMPERMED CORP. LTD.
Date Cleared
2009-03-05
(78 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SIAM SEMPERMED CORP. 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.
The tested chemotherapy drugs are as follows: Amethopterin Hydrate (Methotrexate), Cisplatin, Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), 5-Fluorouracil, Paclitaxel (Taxol), and Vincristine Sulfate.
Device Description
Non sterile, Powder free Nitrile Examination Glove, Lavender Blue with Polymer coated, Tested for use with chemotherapy drugs.
Ask a Question
K Number
K081911Device Name
NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE
Manufacturer
SIAM SEMPERMED CORP. LTD.
Date Cleared
2009-01-15
(196 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SIAM SEMPERMED CORP. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for A pation. Oxamillian worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Non sterile, Powdered Nitrile Examination Glove, Blue
Ask a Question
K Number
K081910Device Name
NON-STERILE, POWDERED LATEX EXAMINATION GLOVE
Manufacturer
SIAM SEMPERMED CORP. LTD.
Date Cleared
2008-09-17
(76 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SIAM SEMPERMED CORP. 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
Non-Sterile, powdered latex examination gloves.
Ask a Question
K Number
K081907Device Name
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
SIAM SEMPERMED CORP. LTD.
Date Cleared
2008-09-03
(62 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SIAM SEMPERMED CORP. 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
Non-Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less)
Ask a Question
K Number
K080520Device Name
NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM
Manufacturer
SIAM SEMPERMED CORP. LTD.
Date Cleared
2008-04-30
(65 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SIAM SEMPERMED CORP. 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 betweeen patient and examiner.
Device Description
Non sterile, Powder free Nitrile Examination Glove, Blue ,Polymer coating with Chemotherapy claim .
Ask a Question
K Number
K070639Device Name
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING
Manufacturer
SIAM SEMPERMED CORP. LTD.
Date Cleared
2007-06-15
(100 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SIAM SEMPERMED CORP. 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 betweeen patient and examiner.
Device Description
Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coating
Ask a Question
Page 1 of 3