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Found 22 results
510(k) Data Aggregation
K Number
K003895Device Name
X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21
Manufacturer
ANSELL PERRY
Date Cleared
2001-01-17
(30 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ANSELL PERRY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002192Device Name
DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38
Manufacturer
ANSELL PERRY
Date Cleared
2000-07-27
(7 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ANSELL PERRY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001239Device Name
ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
ANSELL PERRY
Date Cleared
2000-05-15
(27 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ANSELL PERRY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000165Device Name
NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
Manufacturer
ANSELL PERRY
Date Cleared
2000-03-10
(51 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ANSELL PERRY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000295Device Name
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
ANSELL PERRY
Date Cleared
2000-02-16
(16 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ANSELL PERRY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993857Device Name
THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR
Manufacturer
ANSELL PERRY
Date Cleared
2000-01-31
(77 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ANSELL PERRY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Original Perry Style 42 Surgeon's Glove intended use is to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) meet all of the requirements of ASTM D 3577-99, Type 1. The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-99 Rubber Surgical Gloves. The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
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K Number
K992953Device Name
SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM
Manufacturer
ANSELL PERRY
Date Cleared
1999-10-29
(58 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ANSELL PERRY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim), meet all of the requirements of ASTM D 3577, Type 1. Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim) meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves. Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
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K Number
K992156Device Name
SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES
Manufacturer
ANSELL PERRY
Date Cleared
1999-10-27
(124 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ANSELL PERRY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A sterile disposable device intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner.
Device Description
SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves examination gloves are sterile disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
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K Number
K992768Device Name
NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
Manufacturer
ANSELL PERRY
Date Cleared
1999-10-13
(57 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ANSELL PERRY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Device Description
Nitra-Touch™ Sterile examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
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K Number
K984558Device Name
DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
Manufacturer
ANSELL PERRY
Date Cleared
1999-02-26
(65 days)
Product Code
KGO, RGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ANSELL PERRY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.
Device Description
Derma Prene® Powder-Free Synthetic Surgical Gloves (Chemotherapy Use), meet all of the requirements of ASTM D 3577, Type 2.
Derma Prene® Powder-Free Synthetic Surgical Gloves (Chemotherapy Use) meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves.
Derma Prene® Powder-Free Synthetic Surgical Gloves (Chemotherapy Use) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.
Derma Prene® Powder-Free Synthetic Surgical Gloves (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
Characteristics: Dimensions, Physical Properties, Freedom from holes, Powder-Free, Biocompatability Primary Skin Irritation in Rabbits, Guinea Pig Sensitization
Standard: Meets ASTM D 3577, Meets ASTM D 3577, Type 2, Meets ASTM D 3577, Meets ASTM D 5151, Meets described test in Attachment VI of K980929, Meets ASTM D 6124 Not more than 2 mg residue by mass., Passes, Passes
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