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510(k) Data Aggregation
K Number
K210150Device Name
Disposable Medical mask
Manufacturer
Hubei Wanli Protective Products Co., Ltd.
Date Cleared
2021-06-02
(132 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Hubei Wanli Protective Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Medical 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 Disposable Medical Masks are single use, three-layer, flat –folded masks with ear loops and nose clip. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two strings welded to the facemask. The ear loops are made of 17cm spandex elastic strings(performance of the spandex elastic: Tensile strength greater than or equal to 100N; Elasticity greater than or equal to 2.8times; Breaking tension greater than 100N). The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is not touch with the users' skin directly. The Disposable Medical Masks will be provided in blue. The Disposable Medical Masks are sold non-sterile and are intended to be single use, disposable devices.
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