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Found 10 results
510(k) Data Aggregation
K Number
K111139Device Name
DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U
Manufacturer
ANSELL HEALTHCARE PRODUCTS, INC.
Date Cleared
2011-09-02
(133 days)
Product Code
KGO, LZC
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ANSELL HEALTHCARE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.
Device Description
The Derma Prene® Isotouch® Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs, is a disposable device made of synthetic latex rubber that is intended to be worn by operating room personnel to protect a surgical wound from contamination, and is tested for use with chemotherapy drugs. A coating of Aliphatic Polyester Polyurethane is applied to the inner surface of the glove to make donning easy.
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K Number
K082457Device Name
MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
Manufacturer
ANSELL HEALTHCARE PRODUCTS, INC.
Date Cleared
2008-11-10
(76 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ANSELL HEALTHCARE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
Device Description
Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) meet all of the requirements of ASTM D 6319-00a(2005).
Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) meet all of the current specifications of ASTM D6319-00a(2005), Standard Specification for Nitrile Examination Gloves for Medical Application.
Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are sterile disposable devices to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
Micro-Touch® NitraTex™ Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|--------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Dimensions | Meets ASTM D 6319-00a(2005) |
| Physical Properties | Meets ASTM D 6319-00a(2005) |
| Freedom from Holes | Meets ASTM D 6319-00a(2005)<br>Meets ASTM D 5151-06 |
| Powder-Free | Powder content ≤ 2 mg per glove |
| Biocompatibility:<br>ISO Skin Irritation Study<br>ISO Maximization Sensitization Study - Extract | No irritation<br>No irritation |
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K Number
K042817Device Name
MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
Manufacturer
ANSELL HEALTHCARE PRODUCTS, INC.
Date Cleared
2004-12-06
(55 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ANSELL HEALTHCARE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
Device Description
Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) are non-sterile disposable devices to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
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K Number
K023153Device Name
MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GLYCEROL
Manufacturer
ANSELL HEALTHCARE PRODUCTS, INC.
Date Cleared
2002-11-13
(51 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ANSELL HEALTHCARE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Device Description
Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol are non-sterile disposable devices intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
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K Number
K013603Device Name
MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65
Manufacturer
ANSELL HEALTHCARE PRODUCTS, INC.
Date Cleared
2001-11-13
(13 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ANSELL HEALTHCARE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim) are sterile disposable devices intended to be worn by operating room personnel to protect surgical wounds from contamination.
Device Description
Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-00, Rubber Surgical Gloves, Type 1.
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K Number
K013604Device Name
MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES
Manufacturer
ANSELL HEALTHCARE PRODUCTS, INC.
Date Cleared
2001-11-13
(13 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ANSELL HEALTHCARE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ultralon® Powder Free Latex Surgical Gloves are to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-00, Rubber Surgical Gloves, Type 1.
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K Number
K011593Device Name
MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE
Manufacturer
ANSELL HEALTHCARE PRODUCTS, INC.
Date Cleared
2001-06-21
(28 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ANSELL HEALTHCARE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Device Description
Micro-Touch Nitrile Powder Free Synthetic Medical Examination Gloves are non-sterile disposable devices intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
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K Number
K010961Device Name
X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
ANSELL HEALTHCARE PRODUCTS, INC.
Date Cleared
2001-05-31
(62 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ANSELL HEALTHCARE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003771Device Name
ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
ANSELL HEALTHCARE PRODUCTS, INC.
Date Cleared
2001-01-16
(41 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ANSELL HEALTHCARE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003769Device Name
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87
Manufacturer
ANSELL HEALTHCARE PRODUCTS, INC.
Date Cleared
2000-12-22
(16 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ANSELL HEALTHCARE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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