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510(k) Data Aggregation
K Number
K213001Device Name
Procedure Mask, Surgical Mask
Manufacturer
Date Cleared
2022-05-11
(233 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
A Plus International, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Procedure Masks / Surgical Masks are intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Procedure Masks / Surgical Masks with Polyethylene nose wire can be used in MRI environment.
Device Description
Procedure Mask / Surgical Mask, Ear loops and Tie-On. This is a single use, disposable device(s), provided non-sterile.
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K Number
K102861Device Name
SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)
Manufacturer
Date Cleared
2011-01-13
(105 days)
Product Code
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
A PLUS INTERNATIONAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SurgiPlus Surgical Drapes are single use, disposable patient coverings intended to be used by operating room personnel during surgical and other medical procedures as protective covers to isolate surgical incision sites from microbial and other contaminations.
The SurgiPlus Surgical Drapes are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
The drapes are classified as Level 3 or Level 4 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.
Device Description
SurgiPlus Surgical Drapes are single use, disposable patient coverings. They are made of SMS base sheet with SPP with PE reinforcement or SMS base sheet. They are available in sterile and non-sterile forms.
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K Number
K093169Device Name
SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE)
Manufacturer
Date Cleared
2009-11-12
(36 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
A PLUS INTERNATIONAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SurgiPlus Surgical Gowns are single use article of surgical apparel intended to be worn by operating room personnel during surgical and other medical procedures to protect both the medical personnel and patients from transfer of blood, body fluids, and particulate materials.
Device Description
SurgiPlus Surgical Gowns are single use article of surgical apparel.
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K Number
K031353Device Name
SOLUTION FACE MASKS
Manufacturer
Date Cleared
2003-06-19
(51 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
A PLUS INTERNATIONAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The A Plus International, Inc. Solution Face Masks are designed as surgical apparel medical devices that are intended to fully cover the nose and mouth for infection control, and to be worn (for example) by operating room personnel during surgical procedures, so as to protect both the surgical patient as well as operating room personnel from transfer of microorganisms, body fluids, and particulate materials. Solution Face Masks may be used as isolation masks, procedure masks, or dental face masks, but not as combination surgical and respirator masks. Solution Face Masks are intended as single use disposable devices and not intended for reuse of any kind.
Device Description
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