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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 the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Hua EN Industrial Co, Ltd.. It received FDA 510(k) clearance on 2022-08-17 under 510(k) 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. The listed applicant is Shanghai Hua EN Industrial Co, Ltd.. The 510(k) number is K221838.

When did Surgical Face Mask (HNFM0103) receive FDA 510(k) clearance?

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

Who is the listed applicant for Surgical Face Mask (HNFM0103)?

The FDA 510(k) record lists Shanghai Hua EN Industrial Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Shanghai Hua EN Industrial Co, Ltd. as applicant

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.

K221222Surgical Face Mask (HNFM0304)

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.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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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