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FDA 510(k)

Single-use medical face mask

K-Number: K201974 · 2021-03-07

ApplicantGuangdong Horigen Mother & Baby Products Co., Ltd.
Decision Date2021-03-07
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Single-use medical face mask is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Horigen Mother & Baby Products Co., Ltd.. It received FDA 510(k) clearance on 2021-03-07 under 510(k) number K201974. 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 Single-use medical face mask?

Single-use medical face mask is a medical device that received FDA 510(k) clearance on 2021-03-07. The listed applicant is Guangdong Horigen Mother & Baby Products Co., Ltd.. The 510(k) number is K201974.

When did Single-use medical face mask receive FDA 510(k) clearance?

Single-use medical face mask received FDA 510(k) clearance on 2021-03-07, under 510(k) number K201974.

Who is the listed applicant for Single-use medical face mask?

The FDA 510(k) record lists Guangdong Horigen Mother & Baby Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-use medical face mask?

The FDA product code for Single-use medical face mask is FXX.

Related Clinical Trials

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.

NCT07432607High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window SurgeryRECRUITING

Other records listing Guangdong Horigen Mother & Baby Products 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.

K212564Electric Breast PumpK201152Electric Breast PumpK193449Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)K182413Electric Breast PumpK162747Proture Double Electric Breast Pump

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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