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FDA 510(k)

Surgical Mask (Model: 0868F, 0866F)

K-Number: K221173 · 2022-07-06

ApplicantJiangxi Sanhao Medical Instruments Co.,Ltd
Decision Date2022-07-06
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Mask (Model: 0868F, 0866F) is a medical device manufactured by Jiangxi Sanhao Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2022-07-06 under approval number K221173. 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 Mask (Model: 0868F, 0866F)?

Surgical Mask (Model: 0868F, 0866F) is a medical device that received FDA 510(k) clearance on 2022-07-06. It is manufactured by Jiangxi Sanhao Medical Instruments Co.,Ltd. The 510(k) number is K221173.

When was Surgical Mask (Model: 0868F, 0866F) approved by the FDA?

Surgical Mask (Model: 0868F, 0866F) received FDA 510(k) clearance on 2022-07-06, under approval number K221173.

What company makes Surgical Mask (Model: 0868F, 0866F)?

Surgical Mask (Model: 0868F, 0866F) is manufactured by Jiangxi Sanhao Medical Instruments Co.,Ltd.

What is the FDA product code for Surgical Mask (Model: 0868F, 0866F)?

The FDA product code for Surgical Mask (Model: 0868F, 0866F) is FXX.

Related Clinical Trials

NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING NCT07589946 Integrated Medical, Surgical and Physiotherapy Care for Pregnant Women With Chronic Diseases COMPLETED NCT07557238 CHIP-CC Registry: A Prospective Multicenter Registry of Complex High-Risk PCI in China NOT_YET_RECRUITING NCT07372638 Sensorised Surgical Gloves for Neuroendovascular Procedures NOT_YET_RECRUITING NCT07530133 Clinical Trial on Safety and Efficacy of Thoracoabdominal Endoscopic Surgical System for Pediatric Surgery NOT_YET_RECRUITING

Related PubMed Literature

PMID: 25646114 Transcatheter valve therapy registry is a model for medical device innovation and surveillance. Health affairs (Project Hope) (2015)

Other Devices by Jiangxi Sanhao Medical Instruments Co.,Ltd

K213600Medical nitrile examination gloves (Model: SH001)

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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