Search Results
Found 1 results
510(k) Data Aggregation
K Number
K214094Device Name
ROKI Surgical Mask
Manufacturer
Date Cleared
2022-02-24
(58 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
ROKI Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ROKI Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The ROKI Surgical 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, provided non-sterile.
Model: L and M, white color, and Level 3 barrier level per ASTM F2100-19.
Device Description
The subject device is white color, and flat pleated type mask, utilizing ear loops' way for wearing, and has nose fitter design for fitting the facemask around the nose.
The subject device is consisted of three layers, the inner and outer layers are made with spun-bond polypropylene, and the middle laver is made with melt blown polypropylene.
The subject device is held in place over the user's mouth and nose by two elastic ear loops welded to the mask. The elastic ear loops are made with polyester and polyurethane. The nose fitter contained in the subject device is in the layers of the mask to allow the user to fit the mask around their nose, which is made of malleable aluminum wire.
There are two models of the subject device, Model M. They differ only in the width. Model L is wider than Model M. However, the material formulation, chemical composition, and material 's processing methods are the same. The subject device is a single-use, disposable device, provided non-sterile.
The performance of the subject device meets Level 3 requirements per ASTM F2100-19.
Ask a Question
Ask a specific question about this device
Page 1 of 1