Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Single-use medical face mask

K-Number: K210391 · 2021-07-22

ApplicantZhuhai Herald Datanetics Limited.
Decision Date2021-07-22
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Single-use medical face mask is a medical device manufactured by Zhuhai Herald Datanetics Limited.. It received FDA 510(k) clearance on 2021-07-22 under approval number K210391. 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 2021-07-22. It is manufactured by Zhuhai Herald Datanetics Limited.. The 510(k) number is K210391.

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

Single-use medical face mask received FDA 510(k) clearance on 2021-07-22, under approval number K210391.

What company makes Single-use medical face mask?

Single-use medical face mask is manufactured by Zhuhai Herald Datanetics Limited..

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

NCT07611708 Lubricin-inspired Osteoarthritis Treatment: a Unique Solution NOT_YET_RECRUITING NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT01961557 Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders COMPLETED NCT07614529 Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation NOT_YET_RECRUITING NCT07613658 3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition. NOT_YET_RECRUITING NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED

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)

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.

↑