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FDA 510(k)

ROKI Surgical Mask

K-Number: K214094 · 2022-02-24

ApplicantRoki Co., Ltd.
Decision Date2022-02-24
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ROKI Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Roki Co., Ltd.. It received FDA 510(k) clearance on 2022-02-24 under 510(k) number K214094. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROKI Surgical Mask?

ROKI Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-02-24. The listed applicant is Roki Co., Ltd.. The 510(k) number is K214094.

When did ROKI Surgical Mask receive FDA 510(k) clearance?

ROKI Surgical Mask received FDA 510(k) clearance on 2022-02-24, under 510(k) number K214094.

Who is the listed applicant for ROKI Surgical Mask?

The FDA 510(k) record lists Roki Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROKI Surgical Mask?

The FDA product code for ROKI Surgical Mask is FXX.

Related Devices (Code: FXX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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