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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 a medical device manufactured by Guangdong Horigen Mother & Baby Products Co., Ltd.. It received FDA 510(k) clearance on 2021-03-07 under approval 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. It is manufactured by Guangdong Horigen Mother & Baby Products Co., Ltd.. The 510(k) number is K201974.

When was Single-use medical face mask approved by the FDA?

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

What company makes Single-use medical face mask?

Single-use medical face mask is manufactured by Guangdong Horigen Mother & Baby Products Co., Ltd..

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

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

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Related PubMed Literature

PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026) PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) PMID: 40920948 [The internal condom: overview, practical aspects and analysis of the barriers to its use]. Medecine sciences : M/S (2025)

Other Devices by Guangdong Horigen Mother & Baby Products Co., Ltd.

K162747Proture Double Electric Breast Pump K182413Electric Breast Pump K193449Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) K201152Electric Breast Pump K212564Electric Breast Pump

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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