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510(k) Data Aggregation
K Number
K213177Device Name
Plus Medical Cover Gown
Manufacturer
Foshan Nanhai Plus Medical CO LTD
Date Cleared
2022-05-11
(225 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Foshan Nanhai Plus Medical CO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Plus Medical Cover Gowns are surgical apparel intended to be worn by healthcare professionals to help protect both the patients and the healthcare workers from the transfer of microorganisms, body fluids, and particulate matters. The gowns are single use and disposable medical device provided sterile. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization to ISO 1135-1.
Plus Medical Cover Gowns meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.
Device Description
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K Number
K211036Device Name
Plus Medical Chemotherapy Gown
Manufacturer
Foshan Nanhai Plus Medical CO LTD
Date Cleared
2022-05-04
(392 days)
Product Code
FYA, QSO
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Foshan Nanhai Plus Medical CO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Plus Medical Chemotherapy Gowns are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling and administration. The gowns are a closed back design, single use, disposable medical device provided sterile and non-sterile gowns are to be sold in bulk to re-package:r/e-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
Device Description
Plus Medical Chemotherapy Gowns are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling and administration. The gowns are a closed back design, single use, disposable medical device provided sterile and non-sterile gowns are to be sold in bulk to re-package:r/e-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
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K Number
K212698Device Name
Plus Medical Isolation Gown Level 3
Manufacturer
Foshan Nanhai Plus Medical Co Ltd
Date Cleared
2022-03-02
(189 days)
Product Code
FYC
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Foshan Nanhai Plus Medical Co Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Plus Medical Isolation Gowns Level 3 are intended to be worn by healthcare professionals to help protect both the patients and the healthcare workers from the transfer of microorganisms, body fluids, and particulate matters.
The gown meets the barrier protection requirements of AAMI Level 3 per ANSI/AAMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. The gown is a full-back design and is provided non-sterile, single use medical device.
Device Description
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K Number
K212610Device Name
Surgical Face Mask
Manufacturer
Foshan Nanhai Plus Medical CO LTD
Date Cleared
2022-01-26
(162 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Foshan Nanhai Plus Medical CO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical face masks are intended to be worn to protect both the patient and healthcare 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, provided non-sterile.
Device Description
The Surgical face mask is designed and manufactured by Foshan Nanhai Plus Medical CO LTD. It is non-sterile and for single use. The Surgical face mask is a sandwich structure with the inner and outer layer of polypropylene nonwoven. The middle layer is polypropylene melt-blown nonwoven which provides barrier protection to microorganism, body fluid and particulate aerosol transfer. The ear loop is made with polypropylene nonwoven (tie strap type) or spandex elastic (ear loop type). The Surgical face mask is latex free. It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled.
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K Number
K210143Device Name
Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)
Manufacturer
Foshan Nanhai Plus Medical CO LTD
Date Cleared
2021-07-22
(184 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Foshan Nanhai Plus Medical CO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) are sterile and non-sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter.
The Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) meets the level 3 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
The Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) have been validated using an ethylene oxide sterilization process. The Standard Surgical Gown (AAMI Level 3) and Reinforced Surgical Gown (AAMI Level 3) are also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EtO sterilization method according to ISO 11135-1 prior to being provided to the end user.
Device Description
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