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)

Disposable Medical Face Mask-Model FM-04

K-Number: K202513 · 2021-04-09

ApplicantShenzhen Jinko Industrial Co., Ltd.
Decision Date2021-04-09
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Face Mask-Model FM-04 is a medical device manufactured by Shenzhen Jinko Industrial Co., Ltd.. It received FDA 510(k) clearance on 2021-04-09 under approval number K202513. 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 Disposable Medical Face Mask-Model FM-04?

Disposable Medical Face Mask-Model FM-04 is a medical device that received FDA 510(k) clearance on 2021-04-09. It is manufactured by Shenzhen Jinko Industrial Co., Ltd.. The 510(k) number is K202513.

When was Disposable Medical Face Mask-Model FM-04 approved by the FDA?

Disposable Medical Face Mask-Model FM-04 received FDA 510(k) clearance on 2021-04-09, under approval number K202513.

What company makes Disposable Medical Face Mask-Model FM-04?

Disposable Medical Face Mask-Model FM-04 is manufactured by Shenzhen Jinko Industrial Co., Ltd..

What is the FDA product code for Disposable Medical Face Mask-Model FM-04?

The FDA product code for Disposable Medical Face Mask-Model FM-04 is FXX.

Related Clinical Trials

NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT07572253 A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation NOT_YET_RECRUITING NCT07589946 Integrated Medical, Surgical and Physiotherapy Care for Pregnant Women With Chronic Diseases COMPLETED NCT07337577 Large Language Model-Generated Messages to Improve Guideline-Directed Medical Therapy in Heart Failure NOT_YET_RECRUITING NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION NCT06155695 Auditory Control Enhancement (ACE) in Schizophrenia TERMINATED

Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) 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: 41831468 Cardiometabolic prediction models for young people with psychosis spectrum disorders in the UK (PsyMetRiC 2.0): a retrospective, multicohort clinical prediction model study. The lancet. Psychiatry (2026) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026)

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.

↑