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510(k) Data Aggregation
K Number
K110027Device Name
SURGICAL FACE MASK; SURGICAL FACE MASK
Manufacturer
Date Cleared
2011-08-05
(212 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
ANGELINE GROUP LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Surgical Face Mask, Type: Tie-on, Ear-loop is indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism and body fluid.
Device Description
Angeline Group Ltd. Surgical Face Mask, Type: Tie-on, Ear-loop are pleated 3-ply masks. The outer layers are made with 100% spun-bound polypropylene (SBPP). The filter media is composed of 10000 melt-blown polypropylene (MBPP). The inner layer is made of either 10000 medical grade tissue paper or 10000 SBPP. The ear loops are made of flat latex and fiberglass free elastic. The nosepieces are made of malleable aluminum wire. All of the materials used in the construction of the new masks are being used in currently marketed devices. The Surgical Face Mask, Type: Tie-on, Ear-loop is indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid, and particulate aerosol transfer.
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