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FDA 510(k)

Disposable Surgical Face Mask

K-Number: K210409 · 2021-07-28

ApplicantShandong Zhushi Pharmaceutical Group Co., Ltd.
Decision Date2021-07-28
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Surgical Face Mask is a medical device manufactured by Shandong Zhushi Pharmaceutical Group Co., Ltd.. It received FDA 510(k) clearance on 2021-07-28 under approval number K210409. 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 is a medical device that received FDA 510(k) clearance on 2021-07-28. It is manufactured by Shandong Zhushi Pharmaceutical Group Co., Ltd.. The 510(k) number is K210409.

When was Disposable Surgical Face Mask approved by the FDA?

Disposable Surgical Face Mask received FDA 510(k) clearance on 2021-07-28, under approval number K210409.

What company makes Disposable Surgical Face Mask?

Disposable Surgical Face Mask is manufactured by Shandong Zhushi Pharmaceutical Group Co., Ltd..

What is the FDA product code for Disposable Surgical Face Mask?

The FDA product code for Disposable Surgical Face Mask is FXX.

Other Devices by Shandong Zhushi Pharmaceutical Group Co., Ltd.

K210510Disposable Surgical Gown K210643Disposable Surgical Face Mask K203454Infrared Thermometer K203436Disposable Nitrile Examination Gloves K203439Disposable Vinyl Examination Gloves K212033Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle

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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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