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510(k) Data Aggregation
K Number
K211425Device Name
Private Stock Labs Surgical Face Mask
Manufacturer
J.K. Private Stock Inc.
Date Cleared
2021-10-04
(150 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
J.K. Private Stock Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Private Stock Labs Surgical Face Mask is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. Private Stock Labs Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Device Description
PRIVATE STOCK LABS Surgical Face Mask is a single use, three-layer, flat-pleated mask with ear loops and a nose piece. The Surgical Face Mask is manufactured with three layers, of which 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 face mask. The elastic ear loops are not made with latex materials, but are made of spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of malleable polyethylene wire. The surgical mask will be provided in green of outside and white of inside. PRIVATE STOCK LABS Surgical Face Mask is provided non-sterile and for single use.
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