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FDA 510(k)

Surgical Face Mask

K-Number: K212368 · 2021-10-24

ApplicantAnhui Tiankang Medical Technology Co., Ltd.
Decision Date2021-10-24
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-10-24 under 510(k) number K212368. 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 Face Mask?

Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-10-24. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. The 510(k) number is K212368.

When did Surgical Face Mask receive FDA 510(k) clearance?

Surgical Face Mask received FDA 510(k) clearance on 2021-10-24, under 510(k) number K212368.

Who is the listed applicant for Surgical Face Mask?

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

What is the FDA product code for Surgical Face Mask?

The FDA product code for Surgical Face Mask is FXX.

Other records listing Anhui Tiankang Medical Technology 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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