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FDA 510(k)

AOK 95A Medical Mask (20200049)

K-Number: K220876 · 2022-07-27

ApplicantAok Tooling Limited
Decision Date2022-07-27
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AOK 95A Medical Mask (20200049) is the device name listed in this FDA 510(k) record. The listed applicant is Aok Tooling Limited. It received FDA 510(k) clearance on 2022-07-27 under 510(k) number K220876. 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 AOK 95A Medical Mask (20200049)?

AOK 95A Medical Mask (20200049) is a medical device that received FDA 510(k) clearance on 2022-07-27. The listed applicant is Aok Tooling Limited. The 510(k) number is K220876.

When did AOK 95A Medical Mask (20200049) receive FDA 510(k) clearance?

AOK 95A Medical Mask (20200049) received FDA 510(k) clearance on 2022-07-27, under 510(k) number K220876.

Who is the listed applicant for AOK 95A Medical Mask (20200049)?

The FDA 510(k) record lists Aok Tooling Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AOK 95A Medical Mask (20200049)?

The FDA product code for AOK 95A Medical Mask (20200049) is FXX.

Other records listing Aok Tooling Limited as applicant

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.

K211956039 Surgical Face MaskK201517Plain Surgical Mask

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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