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FDA 510(k)

Procedure Mask, Surgical Mask

K-Number: K202899 · 2021-05-20

ApplicantKenpax International Limited
Decision Date2021-05-20
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Procedure Mask, Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Kenpax International Limited. It received FDA 510(k) clearance on 2021-05-20 under 510(k) number K202899. 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?

Procedure Mask, Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-05-20. The listed applicant is Kenpax International Limited. The 510(k) number is K202899.

When did Procedure Mask, Surgical Mask receive FDA 510(k) clearance?

Procedure Mask, Surgical Mask received FDA 510(k) clearance on 2021-05-20, under 510(k) number K202899.

Who is the listed applicant for Procedure Mask, Surgical Mask?

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

What is the FDA product code for Procedure Mask, Surgical Mask?

The FDA product code for Procedure Mask, Surgical Mask is FXX.

Other records listing Kenpax International 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.

K222128Protective Gown AAMI Level 4K222151Sterilization WrapK212504Isolation Gown AAMI Level 3

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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