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510(k) Data Aggregation
K Number
K212997Device Name
Surgical Mask
Manufacturer
Date Cleared
2022-01-14
(116 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Guangdong Zhizhen Biological Medical Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided sterile. Serial number: ZZ-YYKZ-01, size 175x95mm, Blue ZZ-YYKZ-02, size 145x95mm, Blue ZZ-YYKZ-03.size 175x95mm, Black ZZ-YYKZ-04, size 145x95mm, Black
Device Description
The proposed device, Surgical Mask is a three-layer, plane bandage type mask with ear strap and nose clip. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The proposed device includes masks in two colors and two sizes, as shown in Table 1. The device is single use and provided sterile.
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