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510(k) Data Aggregation
K Number
K233068Device Name
Disposable Surgical Gown
Manufacturer
Nanning TECBOD Biological Technology Co.,Ltd.
Date Cleared
2024-03-29
(185 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Nanning TECBOD Biological Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3/Level 4 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices; provided sterile.
Device Description
Disposable Surgical Gown
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K Number
K223467Device Name
Disposable Isolation Gown
Manufacturer
Nanning TECBOD Biological Technology Co.,Ltd.
Date Cleared
2023-02-10
(85 days)
Product Code
FYC
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Nanning TECBOD Biological Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Isolation Gowns meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Isolation Gowns are single use, disposable medical devices; provided non-sterile.
Device Description
Disposable Isolation Gown is designed for the medical personnel using in medical environment, not intended for use in the operating room. The employed material is a polypropylene and polyethylene (PP+PE) compound non-woven fabric. The color of the gown is blue. The gown has long sleeves with cuffs and neck fasten belts. There are seam tapes above the sleeves and where the sleeves meet the body. The seam tape is ethylene-vinyl acetate (EVA). The material of cuff is polyester and it is elastic.
The body and sleeve of the Disposable Isolation Gowns are constructed from a blue PP+PE compound non-woven fabric and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a Disposable Isolation Gown. The Disposable Isolation Gown is a single use, disposable medical device.
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