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FDA 510(k)

Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)

K-Number: K211750 · 2021-12-20

ApplicantNational Bridge Industrial (S.Z.) Co., Ltd.
Decision Date2021-12-20
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) is a medical device manufactured by National Bridge Industrial (S.Z.) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-20 under approval number K211750. 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 Surgical Face Mask, Disposable Surgical Face Mask (Sterile)?

Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) is a medical device that received FDA 510(k) clearance on 2021-12-20. It is manufactured by National Bridge Industrial (S.Z.) Co., Ltd.. The 510(k) number is K211750.

When was Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) approved by the FDA?

Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) received FDA 510(k) clearance on 2021-12-20, under approval number K211750.

What company makes Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)?

Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) is manufactured by National Bridge Industrial (S.Z.) Co., Ltd..

What is the FDA product code for Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)?

The FDA product code for Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) is FXX.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07529444 Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants RECRUITING

Related PubMed Literature

PMID: 30016835 Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel. Final order. Federal register (2018)

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

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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