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FDA 510(k)

Procedure mask/Surgical mask/Face mask

K-Number: K220194 · 2022-05-17

ApplicantWinner Medical Co., Ltd.
Decision Date2022-05-17
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Procedure mask/Surgical mask/Face mask is a medical device manufactured by Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-05-17 under approval number K220194. 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 Procedure mask/Surgical mask/Face mask?

Procedure mask/Surgical mask/Face mask is a medical device that received FDA 510(k) clearance on 2022-05-17. It is manufactured by Winner Medical Co., Ltd.. The 510(k) number is K220194.

When was Procedure mask/Surgical mask/Face mask approved by the FDA?

Procedure mask/Surgical mask/Face mask received FDA 510(k) clearance on 2022-05-17, under approval number K220194.

What company makes Procedure mask/Surgical mask/Face mask?

Procedure mask/Surgical mask/Face mask is manufactured by Winner Medical Co., Ltd..

What is the FDA product code for Procedure mask/Surgical mask/Face mask?

The FDA product code for Procedure mask/Surgical mask/Face mask is FXX.

Related Clinical Trials

NCT07175129 Transverse Tibial Transport for Chronic Limb-Threatening Ischemia (CLTI) WITHDRAWN NCT07202312 Ozone-therapy in Non-surgical Periodontal Therapy COMPLETED NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07605286 Soft Tissue Augmentation Around Dental Implants 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 Winner Medical Co., Ltd.

K181315Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing K191819Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border K192463PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border K202982Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) K221720Extra Silver Gelling Fiber Dressing K22181935g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown

View all 18 devices →

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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