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FDA 510(k)

Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))

K-Number: K203418 · 2021-09-17

ApplicantNingbo Ouhan Medical Device Co., Ltd.
Decision Date2021-09-17
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) is a medical device manufactured by Ningbo Ouhan Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2021-09-17 under approval number K203418. 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 Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))?

Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) is a medical device that received FDA 510(k) clearance on 2021-09-17. It is manufactured by Ningbo Ouhan Medical Device Co., Ltd.. The 510(k) number is K203418.

When was Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) approved by the FDA?

Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) received FDA 510(k) clearance on 2021-09-17, under approval number K203418.

What company makes Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))?

Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) is manufactured by Ningbo Ouhan Medical Device Co., Ltd..

What is the FDA product code for Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))?

The FDA product code for Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) 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NCT07175129 Transverse Tibial Transport for Chronic Limb-Threatening Ischemia (CLTI) WITHDRAWN NCT07202312 Ozone-therapy in Non-surgical Periodontal Therapy COMPLETED NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in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: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) 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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