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FDA 510(k)

High Fluid-Resistant Surgical and Procedure Mask

K-Number: K222749 · 2022-11-14

ApplicantAmerica’S Supply Chains
Decision Date2022-11-14
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

High Fluid-Resistant Surgical and Procedure Mask is a medical device manufactured by America’S Supply Chains. It received FDA 510(k) clearance on 2022-11-14 under approval number K222749. 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 High Fluid-Resistant Surgical and Procedure Mask?

High Fluid-Resistant Surgical and Procedure Mask is a medical device that received FDA 510(k) clearance on 2022-11-14. It is manufactured by America’S Supply Chains. The 510(k) number is K222749.

When was High Fluid-Resistant Surgical and Procedure Mask approved by the FDA?

High Fluid-Resistant Surgical and Procedure Mask received FDA 510(k) clearance on 2022-11-14, under approval number K222749.

What company makes High Fluid-Resistant Surgical and Procedure Mask?

High Fluid-Resistant Surgical and Procedure Mask is manufactured by America’S Supply Chains.

What is the FDA product code for High Fluid-Resistant Surgical and Procedure Mask?

The FDA product code for High Fluid-Resistant Surgical and Procedure 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Abdominal Surgery COMPLETED NCT07175129 Transverse Tibial Transport for Chronic Limb-Threatening Ischemia (CLTI) WITHDRAWN NCT07610642 Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers NOT_YET_RECRUITING NCT07202312 Ozone-therapy in Non-surgical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)

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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