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FDA 510(k)

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))

K-Number: K212460 · 2021-11-05

ApplicantGuangzhou Zhengkang Medical Equipment Co.,Ltd
Decision Date2021-11-05
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Zhengkang Medical Equipment Co.,Ltd. It received FDA 510(k) clearance on 2021-11-05 under 510(k) number K212460. 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 Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))?

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) is a medical device that received FDA 510(k) clearance on 2021-11-05. The listed applicant is Guangzhou Zhengkang Medical Equipment Co.,Ltd. The 510(k) number is K212460.

When did Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) receive FDA 510(k) clearance?

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) received FDA 510(k) clearance on 2021-11-05, under 510(k) number K212460.

Who is the listed applicant for Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))?

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

What is the FDA product code for Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))?

The FDA product code for Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) is FXX.

Other records listing Guangzhou Zhengkang Medical Equipment 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.

K222204Medical 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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