Search Results
Found 1 results
510(k) Data Aggregation
K Number
K212867Device Name
Medical Surgical Mask
Manufacturer
Nanchang Kanghua Health Materials Co., Ltd
Date Cleared
2021-12-11
(94 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Nanchang Kanghua Health Materials Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The medical surgical mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These 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 medical surgical mask is pleated three-layer mask with ear loops and nose piece. The inner and outer layers are made of spun-bond non-woven fabric. The middle layer is made of melt blown non-woven fabric. only the outer layers' color is blue (colorant: Pigment Blue 15:3 /CAS number: 147-14-8), which is held to cover the users' mouth and nose by two spandex elastic bands ultrasonic welded to the medical surgical mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the medical surgical mask is in the middle layer of medical surgical mask to allow the user to fit the medical surgical mask around their noses, which is made of malleable aluminum wire coated with plastic materials. The dimensions of each medical surgical mask are length 175±5 mm and width 95±5 mm, The dimensions of nose piece is length 110±20 mm, and the ear loop is length 165±10 mm. The medical surgical mask are sold non-sterile and are intended to be single use, disposable devices.
Ask a Question
Page 1 of 1