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510(k) Data Aggregation
K Number
K222480Device Name
Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)
Manufacturer
Foshan Nanhai Plus Medical Co., Ltd.
Date Cleared
2022-11-14
(89 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 2) and Reinforced Surgical Gown (AAMI Level 2) are 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 material.
The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) meets the level 2 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 2) and Reinforced Surgical Gown (AAMI Level 2) have been validated using an ethylene oxide sterilization process. The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) 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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K Number
K133075Device Name
Plus Surgical Gowns (EO Sterilized), PMGB-XXX
Manufacturer
FOSHAN NANHAI PLUS MEDICAL CO., LTD.
Date Cleared
2015-06-24
(632 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
Surgical Gowns (EO Sterilized) are worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room persomel from transfer of microorganisms, body fluids, and particulate material.
Device Description
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K Number
K133080Device Name
Plus Surgical Drapes (EO Sterilized), PMDB-XXX
Manufacturer
FOSHAN NANHAI PLUS MEDICAL CO., LTD.
Date Cleared
2015-06-24
(632 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
FOSHAN NANHAI PLUS MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Surgical Drapes (EO Sterilized) is a single use product used as a protective barrier for patient, such as to isolate a site of surgical incision from microbial and other contamination.
Device Description
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