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FDA 510(k)

Disposable Medical Surgical Face Masks

K-Number: K202211 · 2020-12-22

ApplicantGuangdong Kaidi Garments Co.,Ltd
Decision Date2020-12-22
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Surgical Face Masks is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Kaidi Garments Co.,Ltd. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K202211. 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 Medical Surgical Face Masks?

Disposable Medical Surgical Face Masks is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Guangdong Kaidi Garments Co.,Ltd. The 510(k) number is K202211.

When did Disposable Medical Surgical Face Masks receive FDA 510(k) clearance?

Disposable Medical Surgical Face Masks received FDA 510(k) clearance on 2020-12-22, under 510(k) number K202211.

Who is the listed applicant for Disposable Medical Surgical Face Masks?

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

What is the FDA product code for Disposable Medical Surgical Face Masks?

The FDA product code for Disposable Medical Surgical Face Masks 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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