Search Results
Found 7 results
510(k) Data Aggregation
K Number
K011755Device Name
STRYKER T4 HYTREL (R) TOGAS
Manufacturer
STRYKER CORP.
Date Cleared
2001-06-22
(16 days)
Product Code
LYU
Regulation Number
878.4040Why did this record match?
Product Code :
LYU
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stryker Hytrel® Zippered Toga and Pull-over Toga are components of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
Device Description
The Stryker T4 Personal Protection System: Stryker Hytrel® T4 Togas.
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K Number
K965237Device Name
NURSES BOUFFANT CAP
Manufacturer
COPIOUMED INTL., INC.
Date Cleared
1997-08-27
(239 days)
Product Code
LYU
Regulation Number
878.4040Why did this record match?
Product Code :
LYU
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.
Device Description
CAP, BOUFFANT, NURSES SURGICAL WHITE, BLUE, & GREEN
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K Number
K970988Device Name
FAR-EAST BOUFFANT CAPS
Manufacturer
FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD
Date Cleared
1997-07-10
(114 days)
Product Code
LYU
Regulation Number
878.4040Why did this record match?
Product Code :
LYU
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Far-East Bouffant Caps are disposable devices, intended for medical purposes, that are worn by operating room personnel during surgical procedures to protect form surgical patient and operating room personnel from Burgioal patient and open commons and particulate materials.
Device Description
Far-East Bouffant Caps are disposable devices, intended for medical purposes, that are worn by operating room personnel during surgical procedures to protect form surgical patient and operating room personnel from Burgioal patient and open commons and particulate materials.
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K Number
K964364Device Name
DISPOSABLE APRON
Manufacturer
INSTRUMENT MAKAR, INC.
Date Cleared
1997-02-25
(116 days)
Product Code
LYU
Regulation Number
878.4040Why did this record match?
Product Code :
LYU
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Apron will be used in indications which are the same for that of other aprons. Specifically, the Disposable Apron is intended to be used the hospital environment to protect the healtheare worker from the transfer of micro-organisms. blood, body fluids and particulate material between the worker and the patient. The Disposable Apron is a disposable product intended for single use only.
Device Description
The Disposable Apron is manufactured from 6 gauge Poly Vinyl and is available in a "onc size fits most" size The apron is secured by heing slipped over the head and tied in back
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K Number
K961791Device Name
DEPUY DISPOSABLE FILTER/HOOD
Manufacturer
DEPUY, INC.
Date Cleared
1996-08-09
(92 days)
Product Code
LYU
Regulation Number
878.4040Why did this record match?
Product Code :
LYU
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DePuy Disposable Filter/Hood is intended to be used with the Stryker Steri-Shield System as disposable surgical apparel to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
Device Description
The DePuy Disposable Filter/Hood is a single use, disposable hood with faceshield. The hood is constructed of Dexter paper with spun polypropylene filter media located at the top and back of the hood. The DePuy hood is designed to fit over the Stryker Steri-Shield helmet so that all intake and exhaust air passes through the filter material.
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K Number
K961454Device Name
AMMI MAGNI-GUARD
Manufacturer
AMERICAN MEDICAL MFG., INC.
Date Cleared
1996-07-25
(101 days)
Product Code
LYU
Regulation Number
878.4040Why did this record match?
Product Code :
LYU
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Magni-Guard functions in the same manner as predicate devices in that it provides protection to the surgical staff during surgical procedures.
Device Description
Magni-Guard includes the same components as other marketed predicate devices. The concept of use is to hold it with one hand over a surgical site before releasing clamps from blood vessel grafts or during heavy irrigation to prevent blood splashing. The basic scientific concept that forms the Magni-Guard is that it consists of a clear, rigid, see through plastic. The Guard is made from styrene or PETG. The clear guard has raised side walls throughout its circumference (identical to a Petri-Dish) to prevent the splashing of blood across the surgical suite. It further has an extended handle attached to the circular guard for the surgical site as required intermittently during the surgical procedure.
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K Number
K945302Device Name
SLOAN STA-DRI PANT PROTECTOR
Manufacturer
SLOAN CORP.
Date Cleared
1996-03-19
(567 days)
Product Code
LYU
Regulation Number
878.4040Why did this record match?
Product Code :
LYU
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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