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Found 10 results
510(k) Data Aggregation
K Number
K993117Device Name
SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG
Manufacturer
SAFESKIN CORP.
Date Cleared
2000-03-02
(164 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SAFESKIN CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A medical examination glove intended to be worn on the hands of healthcare personnel and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.
Device Description
The Safeskin PFE-XTRA Examination Glove is a disposable device intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.
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K Number
K994081Device Name
SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES
Manufacturer
SAFESKIN CORP.
Date Cleared
2000-01-18
(46 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SAFESKIN CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A surgeon's glove is intended to be worn on the hands of operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.
Device Description
Safeskin Tactylon® PF powder-free surgical gloves are sterile disposable devices intended to be worn by operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure. Safeskin® Tactylon PF powder-free surgical gloves possess the following technological characteristics (as compared to ASTM or equivalent standards): Dimensions Meets ASTM D 3577, Physical Properties Meets ASTM D 3577, Freedom from pinholes Meets ASTM D 3577 Meets ASTM D 5151, Powder-Free Meets ASTM D 6124 2 mg/glove maximum.
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K Number
K992830Device Name
SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE
Manufacturer
SAFESKIN CORP.
Date Cleared
1999-10-27
(65 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SAFESKIN CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
Device Description
The Safeskin Polymer-Coated Nitrile Examination Glove are sterile disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between personnel and the patient. The Safeskin Polymer-Coated Nitrile Examination Glove possesses the following technological characteristics (as compared to ASTM or equivalent standards): Dimensions Meets ASTM D 3578-99, Physical Properties Meets ASTM D 3578-99, Freedom from pinholes Meets ASTM D 5151, Powder-Free Meets ASTM D 6124 2 mg/glove maximum.
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K Number
K992210Device Name
SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES
Manufacturer
SAFESKIN CORP.
Date Cleared
1999-09-10
(71 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SAFESKIN CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
Device Description
ShieldMaster Powdered Purple Nitrile Gloves are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
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K Number
K992162Device Name
SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM
Manufacturer
SAFESKIN CORP.
Date Cleared
1999-08-30
(66 days)
Product Code
LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SAFESKIN CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.
Device Description
Safeskin Purple Nitrile Examination Gloves are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.
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K Number
K992062Device Name
SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES
Manufacturer
SAFESKIN CORP.
Date Cleared
1999-08-25
(68 days)
Product Code
LZA, DAT
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SAFESKIN CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
Device Description
Safeskin Sterile Purple Nitrile Examination Gloves are sterile disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
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K Number
K991951Device Name
SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE)
Manufacturer
SAFESKIN CORP.
Date Cleared
1999-07-26
(46 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SAFESKIN CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
Device Description
Safeskin Synthetic Powder-Free Examination Gloves are disposable medical gloves intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
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K Number
K991317Device Name
POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
Manufacturer
SAFESKIN CORP.
Date Cleared
1999-05-21
(32 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SAFESKIN CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A surgeon's glove is intended to be worn on the hands of operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.
Device Description
Safeskin® PFS PLUS powder-free latex surgical gloves are sterile disposable devices intended to be worn by operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.
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K Number
K970899Device Name
SAFESKIN POWDERED EXAMINATION GLOVE
Manufacturer
SAFESKIN CORP.
Date Cleared
1997-05-06
(56 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SAFESKIN CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K962139Device Name
SAFESKIN
Manufacturer
SAFESKIN CORP.
Date Cleared
1996-12-19
(199 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SAFESKIN CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A glove 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.
Device Description
This Class I Nitrile patient examination glove (80FMC) is powder-free and meets all the requirements of ASTM Standard D 3578-91 with the exception of pre-aged ultimate elongation. This applicant glove, does however, far exceed the requirements for the only synthetic (non-natural latex) examination glove requirements as described in ASTM D 5250-92. The glove is the same product to which equivalence is claimed, K932404 (Safeskin), except colorant and the Hypoallergenic claim have been added.
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