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510(k) Data Aggregation
K Number
K222529Device Name
Surgical Face Mask
Manufacturer
Xiantao Rayxin Medical Products Co., Ltd.
Date Cleared
2022-11-14
(84 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xiantao Rayxin Medical Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Face Mask is 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(s), provided non-sterile.
Device Description
The Surgical Face Mask is single use, three-layer, flat-pleated style with ear loops/tie-coverall and nose piece. The Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ties/ear loops are held in place over the users' mouth and nose by two ties/ear loops welded to the facemask. The loops are made of polyester and spandex, the ties are made of spun-bond polypropylene. The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of polypropylene and aluminum. The Surgical Face Mask will be provided in blue. The Surgical Face Mask is sold as non-sterile and are intended to be single use, disposable devices.
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K Number
K173847Device Name
Disposable Ultra Reinforced Surgical Gown
Manufacturer
Xiantao Rayxin Medical Products Co., ltd.
Date Cleared
2019-01-16
(393 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xiantao Rayxin Medical Products Co., ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Ultra Reinforced Surgical Gown is 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. In addition, this surgical gown 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. It is single use, disposable medical devices, provided sterile
Device Description
The Disposable Ultra Reinforced Surgical Gown is reinforced surgical gown, which is comprised of a single layer blue non-woven fabric SMS, and an additional layer of SMS in critical zones of sleeve and front chest. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.
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K Number
K153496Device Name
Disposable Surgical Face Mask
Manufacturer
XIANTAO RAYXIN MEDICAL PRODUCTS CO., LTD.
Date Cleared
2016-06-15
(191 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
XIANTAO RAYXIN MEDICAL PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable 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(s), provided non-sterile.
Device Description
The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose. The blue colorant is polypropylene (PP) master batch.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, tie-on, is held in place over the uers's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the uers's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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