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510(k) Data Aggregation
K Number
K022868Device Name
PRIMAGARD SURGICAL EQUIPMENT DRAPES
Manufacturer
PRIMELINE MEDICAL PRODUCTS, INC.
Date Cleared
2002-11-08
(71 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
PRIMELINE MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The primaGARD Surgical Equipment Covers are Non-sterile surgical equipment covers, identified in 21 CFR, part 878.4370. The drapes are made of natural and/or synthetic material and used as a protective equipment covering. The primary purpose of this drape is to isolate equipment from contaminating the sterile field during surgery. This is to maintain the sterile technique in an operating room.
Device Description
The primaGARD Surgical Equipment Covers are Non-sterile surgical equipment covers, identified in 21 CFR, part 878.4370. The drapes are made of natural and/or synthetic material and used as a protective equipment covering.
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K Number
K023117Device Name
PRIMAGARD SURGICAL GOWNS
Manufacturer
PRIMELINE MEDICAL PRODUCTS, INC.
Date Cleared
2002-11-08
(58 days)
Product Code
KKX, FYA
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
PRIMELINE MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The primaGARD Surgical Drapes are Non-sterile Surgical Gowns, identified in 21 CFR, part 878.400, as a medical device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Device Description
primaGARD Surgical Gowns
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K Number
K023266Device Name
PRIMAGARD SURGICAL GOWNS
Manufacturer
PRIMELINE MEDICAL PRODUCTS, INC.
Date Cleared
2002-11-08
(39 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
PRIMELINE MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The primaGARD Surgical Drapes are Non-sterile Surgical Gowns, identified in 21 CFR, part 878.4970, as a medical device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Device Description
primaGARD Surgical Gowns
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K Number
K021864Device Name
PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142)
Manufacturer
PRIMELINE MEDICAL PRODUCTS, INC.
Date Cleared
2002-09-23
(109 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
PRIMELINE MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The primaGARD Surgical Drapes are NoNSterile Surgical Drape, identified in 21 CFR, part 878.4730, as a medical device intended to be used by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The drapes are made of natural and/or synthetic material and used as a protective patient covering. One example of use of this drape is to isolate the site of surgical incision from particulate, microbial and other forms of contamination.
Device Description
The primaGARD Surgical Drapes are NoNSterile Surgical Drape, identified in 21 CFR, part 878.4730, as a medical device intended to be used by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The drapes are made of natural and/or synthetic material and used as a protective patient covering.
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K Number
K021076Device Name
PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM
Manufacturer
PRIMELINE MEDICAL PRODUCTS, INC.
Date Cleared
2002-04-16
(13 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
PRIMELINE MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Surgical Masks are surgical apparel, identified in 21 CFR, part 878.4040, as a medical device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Device Description
Not Found
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K Number
K011789Device Name
PROCEDURE MASKS: PM4-301 AND PM4-304
Manufacturer
PRIMELINE MEDICAL PRODUCTS, INC.
Date Cleared
2001-06-22
(14 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
PRIMELINE MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Surgical Masks are surgical apparel, identified in 21 CFR, part 878.4040, as a medical device intended to be world by operating room personnel from the transfer of protect bour the barger fluids, and particulate matcrial.
Device Description
Procedure Masks PM 4-301 + Pm4-31
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K Number
K001951Device Name
PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306
Manufacturer
PRIMELINE MEDICAL PRODUCTS, INC.
Date Cleared
2000-09-08
(73 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
PRIMELINE MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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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?
Applicant Name (Manufacturer) :
PRIMELINE MEDICAL PRODUCTS, INC.
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
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K Number
K971075Device Name
PRIMED PRIME-PLUS COTTON GAUZE SPONGES
Manufacturer
PRIMELINE MEDICAL PRODUCTS, INC.
Date Cleared
1997-06-22
(90 days)
Product Code
EFQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PRIMELINE MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cotton Gauze Sponges are designed as single use, and general use medical devices in the management of wounds.
Device Description
Cotton Gauze Sponges
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