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510(k) Data Aggregation
K Number
K213347Device Name
ADI Medical Surgical Face Mask
Manufacturer
Date Cleared
2022-01-25
(109 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Asia Dynamics Inc., d/b/a ADI Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ADI Medical Surgical 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 of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Device Description
The ADI Medical Surgical Face Masks are single use, three-layer, flat -folded masks with ear loops and nose clamp. The ADI Medical Surgical Face Masks 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 ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. ADI Medical Surgical Face Masks will be provided in blue. ADI Medical Surgical Face Masks are sold non-sterile and are intended to be single use, disposable devices.
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