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FDA 510(k)

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW

K-Number: K203078 · 2022-08-19

ApplicantHuizhou Tianchang Industrial Co., Ltd.
Decision Date2022-08-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Tianchang Industrial Co., Ltd.. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K203078. 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 CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW?

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Huizhou Tianchang Industrial Co., Ltd.. The 510(k) number is K203078.

When did CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW receive FDA 510(k) clearance?

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW received FDA 510(k) clearance on 2022-08-19, under 510(k) number K203078.

Who is the listed applicant for CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW?

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

What is the FDA product code for CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW?

The FDA product code for CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW 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

View on FDA Database →

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

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