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510(k) Data Aggregation
K Number
K212273Device Name
Cross Protection ResQ300 Plus Surgical Face Mask
Manufacturer
Date Cleared
2022-08-17
(393 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Cross Protection (M) Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Cross Protection ResQ300 Plus Surgical Face Masks are intended to be used as isolation face mask and dental face mask.
Cross Protection ResQ300 Plus Surgical Face Masks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transms, bodily fluids and particulate material.
Device Description
The Cross Protection® ResQ300 Plus Surgical Facemask is a pleated, multi-ply design, which is a nonsterile, single use, disposable device. The mask covers the nose and mouth and is secured to the face using the attached ear loops or attached ties.
The outer layer is made of 100% blue spun-bond polypropylene. The middle layer is filter media composed of 100% white melt-blown polypropylene. The inner (patient contacting) layer is made of either 100% white spun-bond polypropylene or 100% white medical grade tissue paper.
The ear attachments are either Ear Loop style. Ear Loops are made of elastic and the Tie-On straps are made of 100% white spun-bond polypropylene.
The nosepiece is made of malleable aluminum.
All materials used in the construction of the mask are being used in currently marketed devices.
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