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510(k) Data Aggregation
K Number
K214088Device Name
Disposable Surgical Gown
Manufacturer
Date Cleared
2022-04-12
(105 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Disposable 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 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. It is single use, disposable medical devices, provided sterile.
Device Description
The subject devices 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 materials.
In addition, this surgical gown meets the requirements of AAMI Level 4 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.
The proposed device is single use, disposable medical devices and provided sterile.
The main materials of device are SMS nonwoven +TPU membrane, PP and Polyester fiber, and the main manufacturing technique are Ultrasonic welding and Sewing.
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K Number
K220133Device Name
Sterilization Wraps
Manufacturer
Date Cleared
2022-03-10
(51 days)
Product Code
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sterilization Wraps is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
• Pre-vacuum steam at 270°F/132°C for 4 minutes
Types of medical devices to be sterilized in the pre-vacuum cycle:
General purpose reusable metal and nonmetal devices(No lumen) including devices with stainless steel diffusionrestricted spaces such as forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
The size of the Devices to be sterilization Wraps pack and form a closed space. Validated for dry time is 30 minutes for Sterilization Wraps.
Color of wrap: Blue Size of wrap: 48 in x 48 in
The maximum validated weight of load for Sterilization Wraps is 12kg.
The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.
Device Description
Sterilization Wraps is a 63gsm, latex-free, 3-layer (SMS) non-woven sterile wrap, manufactured with spun-bonded / meltblown polypropylenem. Sterilization Wraps provides a strong barrier which protects against cuts, tears with particularly heavy orthopedic sets. Sterilization Wraps is designed to be implemented as an outer sterilization wrap which can be used in combination with Clinipak choice. Sterilization Wraps is made of polypropylene and blue pigment by non-woven process.
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K Number
K213029Device Name
Nitrile Examination Gloves (Powder free, Blue)
Manufacturer
Date Cleared
2021-12-14
(84 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nitrile Examination Gloves (Powder free, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Device Description
The proposed device, Nitrile Examination Gloves (Powder free, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size. The color of the proposed device is Blue.
The proposed device is provided non-sterile. The proposed device is made of Nitrile.
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K Number
K212807Device Name
Surgical Masks
Manufacturer
Date Cleared
2021-12-03
(91 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Surgical Masks is 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 Model YH-EZ-004(White Color, Blue Color) is Level 2 barrier as ASTM F2100 requirements.
Device Description
The proposed device(s) includes 1 model, which is YH-EZ-004. This model has two colors, Blue color and White color. This model is Flat Pleated type mask, utilizing Ear Loops' way for wearing, and it has Nose Piece design for fitting the facemask around the nose.
All two colors of the model YH-EZ-004 of proposed device(s) share same materials and structure, they all are manufactured with three layers, the inner and outer layers are made of spunbonded non-woven fabric, and the middle layer is made of melt-blown non-woven fabric.
The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polyethylene.
The proposed device(s) is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with terylene and spandex.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
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