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FDA 510(k)

Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)

K-Number: K211827 · 2021-09-23

ApplicantZhejiang Lanhine Medical Products, Ltd.
Decision Date2021-09-23
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) is a medical device manufactured by Zhejiang Lanhine Medical Products, Ltd.. It received FDA 510(k) clearance on 2021-09-23 under approval number K211827. 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 Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)?

Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) is a medical device that received FDA 510(k) clearance on 2021-09-23. It is manufactured by Zhejiang Lanhine Medical Products, Ltd.. The 510(k) number is K211827.

When was Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) approved by the FDA?

Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) received FDA 510(k) clearance on 2021-09-23, under approval number K211827.

What company makes Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)?

Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) is manufactured by Zhejiang Lanhine Medical Products, Ltd..

What is the FDA product code for Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)?

The FDA product code for Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) is FXX.

Related Clinical Trials

NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07175129 Transverse Tibial Transport for Chronic Limb-Threatening Ischemia (CLTI) WITHDRAWN NCT07610642 Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers NOT_YET_RECRUITING NCT07202312 Ozone-therapy in Non-surgical Periodontal Therapy COMPLETED NCT07612644 Hemorrhage Elimination During Lumbar Puncture Using Ultrasound Measurements (HELPUS) RECRUITING NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (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) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Zhejiang Lanhine Medical Products, Ltd.

K211832Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask

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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