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510(k) Data Aggregation
K Number
K212649Device Name
Disposable Surgical Face Mask
Manufacturer
Lyncmed Medical Technology (Beijing) Co., Ltd.
Date Cleared
2022-10-25
(428 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Lyncmed Medical Technology (Beijing) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable surgical face mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
Device Description
The proposed device, Disposable Surgical Face Mask is a three-layer, flat-folded mask. The mask body is made of 25g/m2 polypropylene (PP) non-woven cloth. The mask contains tie strings or ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Polyurethane and spandex, and tie strings are made of polypropylene nonwoven cloth. The nose clip which is made of Iron-Zinc strip covered by polyethylene terephthalate (PET) covering. The disposable surgical face mask is available in two different specifications: 17.5×9.5cm and 16.5×8.5cm. The device is single use and provided sterile.
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K Number
K211586Device Name
Nitrile Examination Gloves (Blue, Violet)
Manufacturer
Lyncmed Medical Technology (Beijing) Co., Ltd.
Date Cleared
2021-11-01
(161 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Lyncmed Medical Technology (Beijing) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitrile Examination Gloves is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
The proposed device, Nitrile Examination Gloves (Blue, Violet) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The color of the proposed device is Blue and Violet. The proposed device is not provided as sterilized. The proposed device is made of Nitrile.
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