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FDA 510(k)

Surgical Masks

K-Number: K203524 · 2021-02-25

ApplicantBain Medical Equipment (Guangzhou) Co., Ltd.
Decision Date2021-02-25
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Masks is the device name listed in this FDA 510(k) record. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-02-25 under 510(k) number K203524. 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 Surgical Masks?

Surgical Masks is a medical device that received FDA 510(k) clearance on 2021-02-25. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. The 510(k) number is K203524.

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

Surgical Masks received FDA 510(k) clearance on 2021-02-25, under 510(k) number K203524.

Who is the listed applicant for Surgical Masks?

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

What is the FDA product code for Surgical Masks?

The FDA product code for Surgical Masks is FXX.

Other records listing Bain Medical Equipment (Guangzhou) Co., Ltd. as applicant

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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.

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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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