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510(k) Data Aggregation
K Number
K101000Device Name
WELLMIEN SURGICAL MASK
Date Cleared
2010-08-09
(119 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
**WELLMIEN (SUZHOU) IMPORT **& EXPORT TRADING CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Wellmien Surgical Masks (for single use only) are 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 situations where there is a risk of microorganism, body fluid, and particulate aerosol transfer.
Device Description
WELLMIEN's surgical masks (for single use only) are pleated 3-ply mask. Inner and outer layers are made of 100% spun-bond polypropylene. Middle player is made of 100% meltblown polypropylene filter media. Ear-loops are made of soft elastic loops. The nose piece for all WELLMIEN's face masks is malleable aluminum wire. All of the materials used in the construction of the WELLMIEN's surgical masks are being used in currently marketed devices.
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