Search Results
Found 5 results
510(k) Data Aggregation
K Number
K971076Device Name
PRIMED SHOE COVERS, PRIMED HEAD COVERS
Manufacturer
PRIMELINE MEDICAL PRODUCTS, INC.
Date Cleared
1998-01-13
(295 days)
Product Code
FXP
Regulation Number
878.4040Why did this record match?
Product Code :
FXP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Surgical Apparels, shoe and head covers, are worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Device Description
PrimeLine Medical Products Inc., priMED brand Head and Shoe Covers
Ask a Question
K Number
K971191Device Name
FAR-EAST SHOE COVERS
Manufacturer
FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD
Date Cleared
1997-07-10
(101 days)
Product Code
FXP
Regulation Number
878.4040Why did this record match?
Product Code :
FXP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Far-East Shoe Covers are disposable and single used devices, intended for medical purposes, that are worn on to cover the shoes of all personnel during the general medical procedures, or surgical procedures to protect the medical personnel, or surgical personnel from transfer of bacteria, micro-organisms and particulate material.
Device Description
Far-East Shoe Covers are disposable and single used devices, intended for medical purposes, that are worn on to cover the shoes of all personnel during the general medical procedures, or surgical procedures to protect the medical personnel, or surgical personnel from transfer of bacteria, micro-organisms and particulate material.
Ask a Question
K Number
K970815Device Name
CONVERTORS IMPERVIOUS SHOE COVERS
Manufacturer
ALLEGIANCE HEALTHCARE CORP.
Date Cleared
1997-03-27
(21 days)
Product Code
FXP
Regulation Number
878.4040Why did this record match?
Product Code :
FXP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Convertors® Impervious Shoe Covers are devices intended 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
These shoe covers will be composed of a nonwoven fabric hot melt adhesively laminated to a synthetic polymer film. The nonwoven is a 1.5 osy blue spunbonded polypropylene. The film is a 1.25 mil embossed, polyethylene.
Ask a Question
K Number
K961342Device Name
SHOE COVER, NON-STERILE
Manufacturer
COPIOUMED INTL., INC.
Date Cleared
1996-12-30
(285 days)
Product Code
FXP
Regulation Number
878.4040Why did this record match?
Product Code :
FXP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K955835Device Name
FLUID BARRIER BOOT KNEE & ANKLE-HIGH
Manufacturer
INSTRUMENT MAKAR, INC.
Date Cleared
1996-11-19
(329 days)
Product Code
FXP
Regulation Number
878.4040Why did this record match?
Product Code :
FXP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fluid Barrier Boot is intended to be used in the hospital environment to provide protection from all types of fluids in the Operating Room, Central Sterile and in the Emergency Room.
Device Description
The Fluid Barrier Boot is manufactured from 6 gauge Poly Vinyl and is available in both knee-high or ankle high boots is small, medium or large sizes. The boots are secured with straps both at the ankle and over the call on the knee-high boot. The ankle-high boot secures only at the ankle.
Ask a Question
Page 1 of 1