Search Results
Found 1 results
510(k) Data Aggregation
K Number
K211255Device Name
Surgical Mask
Manufacturer
Date Cleared
2021-08-28
(124 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Tianchang Kanghui Protective Products CO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Surgical Mask (model: KH8001& KH8002) is intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
Device Description
The proposed devices (model: KH8001& KH8002) are White color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose.
The proposed devices 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, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of polyester fiber and spandex. The nose piece in the proposed devices is made of Galvanized wire with polypropylene and is contained within the layers of face mask to allow the user to fit the face mask around their nose. The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
Ask a Question
Ask a specific question about this device
Page 1 of 1