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FDA 510(k)

Heartland Health Surgical Mask

K-Number: K212366 · 2022-02-19

ApplicantHeartland Health Products
Decision Date2022-02-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Heartland Health Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Heartland Health Products. It received FDA 510(k) clearance on 2022-02-19 under 510(k) number K212366. 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 Heartland Health Surgical Mask?

Heartland Health Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-02-19. The listed applicant is Heartland Health Products. The 510(k) number is K212366.

When did Heartland Health Surgical Mask receive FDA 510(k) clearance?

Heartland Health Surgical Mask received FDA 510(k) clearance on 2022-02-19, under 510(k) number K212366.

Who is the listed applicant for Heartland Health Surgical Mask?

The FDA 510(k) record lists Heartland Health Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Heartland Health Surgical Mask?

The FDA product code for Heartland Health Surgical 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.

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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