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FDA 510(k)

Disposable Surgical Mask/Fluid Resistant Procedure Mask

K-Number: K202240 · 2021-02-25

ApplicantLhm Medical Technology (Hong Kong) Limited
Decision Date2021-02-25
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Surgical Mask/Fluid Resistant Procedure Mask is the device name listed in this FDA 510(k) record. The listed applicant is Lhm Medical Technology (Hong Kong) Limited. It received FDA 510(k) clearance on 2021-02-25 under 510(k) number K202240. 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 Disposable Surgical Mask/Fluid Resistant Procedure Mask?

Disposable Surgical Mask/Fluid Resistant Procedure Mask is a medical device that received FDA 510(k) clearance on 2021-02-25. The listed applicant is Lhm Medical Technology (Hong Kong) Limited. The 510(k) number is K202240.

When did Disposable Surgical Mask/Fluid Resistant Procedure Mask receive FDA 510(k) clearance?

Disposable Surgical Mask/Fluid Resistant Procedure Mask received FDA 510(k) clearance on 2021-02-25, under 510(k) number K202240.

Who is the listed applicant for Disposable Surgical Mask/Fluid Resistant Procedure Mask?

The FDA 510(k) record lists Lhm Medical Technology (Hong Kong) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Surgical Mask/Fluid Resistant Procedure Mask?

The FDA product code for Disposable Surgical Mask/Fluid Resistant Procedure 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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