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FDA 510(k)

ASM-301 Level 3 Surgical Mask

K-Number: K211440 · 2021-06-02

ApplicantAmerican Surgical Mask Company, LLC
Decision Date2021-06-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ASM-301 Level 3 Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is American Surgical Mask Company, LLC. It received FDA 510(k) clearance on 2021-06-02 under 510(k) number K211440. 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 ASM-301 Level 3 Surgical Mask?

ASM-301 Level 3 Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-06-02. The listed applicant is American Surgical Mask Company, LLC. The 510(k) number is K211440.

When did ASM-301 Level 3 Surgical Mask receive FDA 510(k) clearance?

ASM-301 Level 3 Surgical Mask received FDA 510(k) clearance on 2021-06-02, under 510(k) number K211440.

Who is the listed applicant for ASM-301 Level 3 Surgical Mask?

The FDA 510(k) record lists American Surgical Mask Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASM-301 Level 3 Surgical Mask?

The FDA product code for ASM-301 Level 3 Surgical Mask 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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