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)

Surgical face mask (Model: Flat Ear Loop/CN102)

K-Number: K203534 · 2021-07-21

ApplicantCrown Name Disposable Hygiene Products Fty., Ltd.
Decision Date2021-07-21
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical face mask (Model: Flat Ear Loop/CN102) is a medical device manufactured by Crown Name Disposable Hygiene Products Fty., Ltd.. It received FDA 510(k) clearance on 2021-07-21 under approval number K203534. 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 face mask (Model: Flat Ear Loop/CN102)?

Surgical face mask (Model: Flat Ear Loop/CN102) is a medical device that received FDA 510(k) clearance on 2021-07-21. It is manufactured by Crown Name Disposable Hygiene Products Fty., Ltd.. The 510(k) number is K203534.

When was Surgical face mask (Model: Flat Ear Loop/CN102) approved by the FDA?

Surgical face mask (Model: Flat Ear Loop/CN102) received FDA 510(k) clearance on 2021-07-21, under approval number K203534.

What company makes Surgical face mask (Model: Flat Ear Loop/CN102)?

Surgical face mask (Model: Flat Ear Loop/CN102) is manufactured by Crown Name Disposable Hygiene Products Fty., Ltd..

What is the FDA product code for Surgical face mask (Model: Flat Ear Loop/CN102)?

The FDA product code for Surgical face mask (Model: Flat Ear Loop/CN102) 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

Other Devices by Crown Name Disposable Hygiene Products Fty., Ltd.

K212422Disposable Surgical Isolation Gown

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.

↑