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510(k) Data Aggregation
(58 days)
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.
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.
The provided text describes the acceptance criteria and performance data for the ROKI Surgical Mask, demonstrating its substantial equivalence to a predicate device (Qiqihar Hengxin Medical Supplies, Ltd. Single-Use Surgical Mask, K201924). The device's performance was evaluated against ASTM F2100-19 Level 3 requirements.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (ASTM F2100-19 Level 3) | Reported Device Performance (Model L) | Reported Device Performance (Model M) |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | 160 mmHg | 160 mmHg (96/96 no penetration) | 160 mmHg (96/96 no penetration) |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | ≥ 98.09% | ≥ 98.07% |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | ≥ 98.1% | ≥ 98.1% |
| Differential Pressure (Delta-P) (EN14683) |
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(77 days)
High density restorative for cavity preparation in posterior teeth. May be used as an indirect restorative for inlays and onlays.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental device called "ROK." It primarily confirms the device's substantial equivalence to a legally marketed predicate device and does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria.
Therefore, I cannot provide the requested information based on the input text. The document focuses on regulatory approval based on equivalence, not on a detailed performance study with acceptance criteria.
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