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FDA 510(k)

Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP

K-Number: K220749 · 2022-05-13

ApplicantUnimax Medical Products Co., Ltd.
Decision Date2022-05-13
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP is a medical device manufactured by Unimax Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-05-13 under approval number K220749. 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 Face Mask, Model Number-17.5X9.5CM EAR-LOOP?

Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP is a medical device that received FDA 510(k) clearance on 2022-05-13. It is manufactured by Unimax Medical Products Co., Ltd.. The 510(k) number is K220749.

When was Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP approved by the FDA?

Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP received FDA 510(k) clearance on 2022-05-13, under approval number K220749.

What company makes Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP?

Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP is manufactured by Unimax Medical Products Co., Ltd..

What is the FDA product code for Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP?

The FDA product code for Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP 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 Unimax Medical Products Co., Ltd.

K221717Disposable Surgical Gown UM-148

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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