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FDA 510(k)

Kangbeier Surgical Mask (Model: KBR-1001)

K-Number: K213920 · 2022-01-16

ApplicantXinxiang Kangbeier Medical Technology Co., Ltd.
Decision Date2022-01-16
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Kangbeier Surgical Mask (Model: KBR-1001) is the device name listed in this FDA 510(k) record. The listed applicant is Xinxiang Kangbeier Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-16 under 510(k) number K213920. 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 Kangbeier Surgical Mask (Model: KBR-1001)?

Kangbeier Surgical Mask (Model: KBR-1001) is a medical device that received FDA 510(k) clearance on 2022-01-16. The listed applicant is Xinxiang Kangbeier Medical Technology Co., Ltd.. The 510(k) number is K213920.

When did Kangbeier Surgical Mask (Model: KBR-1001) receive FDA 510(k) clearance?

Kangbeier Surgical Mask (Model: KBR-1001) received FDA 510(k) clearance on 2022-01-16, under 510(k) number K213920.

Who is the listed applicant for Kangbeier Surgical Mask (Model: KBR-1001)?

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

What is the FDA product code for Kangbeier Surgical Mask (Model: KBR-1001)?

The FDA product code for Kangbeier Surgical Mask (Model: KBR-1001) is FXX.

Other records listing Xinxiang Kangbeier Medical Technology Co., Ltd. as applicant

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.

K221753Kangbeier Child Surgical Mask

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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