Search Results
Found 1 results
510(k) Data Aggregation
K Number
K213806Device Name
Disposable Medical Face Mask
Manufacturer
Xiantao Zhibo Nonwoven Products Co., Ltd
Date Cleared
2022-03-12
(96 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xiantao Zhibo Nonwoven Products Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Medical 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
Disposable Medical Face Mask is composed of Nylon & Spandex Ear loops, High Density Polyethylene nose clip, Inner layer Non-woven fabric, Middle Melt-blown Non-woven fabric and outer Non-woven fabric. The melt-blown material acts as the filter that stops microbes from entering or exiting the mask. Disposable Medical Face Mask feature pleats. Three pleats are used to expand the mask such that it covers the area from the nose to the chin. The type is ear loop, where a string-like material is attached to the mask and placed behind the ears. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
Ask a Question
Page 1 of 1