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 Mask-Model Number CW01

K-Number: K202354 · 2020-09-08

ApplicantHunan Heng Chang Pharmaceutical Co., Ltd.
Decision Date2020-09-08
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Mask-Model Number CW01 is a medical device manufactured by Hunan Heng Chang Pharmaceutical Co., Ltd.. It received FDA 510(k) clearance on 2020-09-08 under approval number K202354. 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 Number CW01?

Surgical Mask-Model Number CW01 is a medical device that received FDA 510(k) clearance on 2020-09-08. It is manufactured by Hunan Heng Chang Pharmaceutical Co., Ltd.. The 510(k) number is K202354.

When was Surgical Mask-Model Number CW01 approved by the FDA?

Surgical Mask-Model Number CW01 received FDA 510(k) clearance on 2020-09-08, under approval number K202354.

What company makes Surgical Mask-Model Number CW01?

Surgical Mask-Model Number CW01 is manufactured by Hunan Heng Chang Pharmaceutical Co., Ltd..

What is the FDA product code for Surgical Mask-Model Number CW01?

The FDA product code for Surgical Mask-Model Number CW01 is FXX.

Related Clinical Trials

NCT02107989 Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database RECRUITING NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07561372 Adaptive Recruitment Curve Analysis Using Bayesian Modeling NOT_YET_RECRUITING NCT07034521 The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors RECRUITING

Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 40902105 Design of Automatic Tool Replacement Mechanism for Laparoscopic Surgical Robot Arm for Solo Surgery. The international journal of medical robotics + computer assisted surgery : MRCAS (2025)

Other Devices by Hunan Heng Chang Pharmaceutical Co., Ltd.

K202358Protective Face Mask for Medical Use

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.

↑