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)

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask

K-Number: K211832 · 2021-09-08

ApplicantZhejiang Lanhine Medical Products, Ltd.
Decision Date2021-09-08
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask is a medical device manufactured by Zhejiang Lanhine Medical Products, Ltd.. It received FDA 510(k) clearance on 2021-09-08 under approval number K211832. 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 Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask?

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-09-08. It is manufactured by Zhejiang Lanhine Medical Products, Ltd.. The 510(k) number is K211832.

When was Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask approved by the FDA?

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask received FDA 510(k) clearance on 2021-09-08, under approval number K211832.

What company makes Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask?

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask is manufactured by Zhejiang Lanhine Medical Products, Ltd..

What is the FDA product code for Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask?

The FDA product code for Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask 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Abdominal Surgery COMPLETED NCT07175129 Transverse Tibial Transport for Chronic Limb-Threatening Ischemia (CLTI) WITHDRAWN NCT07610642 Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers NOT_YET_RECRUITING NCT07202312 Ozone-therapy in Non-surgical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 NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED

Related PubMed Literature

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.

K211827Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)

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.

↑