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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 the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Ouhan Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2021-09-17 under 510(k) 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. The listed applicant is Ningbo Ouhan Medical Device Co., Ltd.. The 510(k) number is K203418.

When did Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) receive FDA 510(k) clearance?

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

Who is the listed applicant for Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))?

The FDA 510(k) record lists Ningbo Ouhan Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: FXX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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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