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FDA 510(k)

Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask

K-Number: K211462 · 2021-08-19

Decision Date2021-08-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Xiantao S&J Protective Products Co., Ltd.. It received FDA 510(k) clearance on 2021-08-19 under 510(k) number K211462. 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 Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask?

Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is Xiantao S&J Protective Products Co., Ltd.. The 510(k) number is K211462.

When did Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask receive FDA 510(k) clearance?

Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask received FDA 510(k) clearance on 2021-08-19, under 510(k) number K211462.

Who is the listed applicant for Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask?

The FDA 510(k) record lists Xiantao S&J Protective Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask?

The FDA product code for Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask 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.

Official Source

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