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FDA 510(k)

Surgical Face Mask (HNFM0103)

K-Number: K221838 · 2022-08-17

ApplicantShanghai Hua EN Industrial Co, Ltd.
Decision Date2022-08-17
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Face Mask (HNFM0103) is a medical device manufactured by Shanghai Hua EN Industrial Co, Ltd.. It received FDA 510(k) clearance on 2022-08-17 under approval number K221838. 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 (HNFM0103)?

Surgical Face Mask (HNFM0103) is a medical device that received FDA 510(k) clearance on 2022-08-17. It is manufactured by Shanghai Hua EN Industrial Co, Ltd.. The 510(k) number is K221838.

When was Surgical Face Mask (HNFM0103) approved by the FDA?

Surgical Face Mask (HNFM0103) received FDA 510(k) clearance on 2022-08-17, under approval number K221838.

What company makes Surgical Face Mask (HNFM0103)?

Surgical Face Mask (HNFM0103) is manufactured by Shanghai Hua EN Industrial Co, Ltd..

What is the FDA product code for Surgical Face Mask (HNFM0103)?

The FDA product code for Surgical Face Mask (HNFM0103) is FXX.

Other Devices by Shanghai Hua EN Industrial Co, Ltd.

K221222Surgical Face Mask (HNFM0304)

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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