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FDA 510(k)

Allmed Surgical Face Masks (Ear loops)

K-Number: K202128 · 2021-06-03

ApplicantAllmed Medical Products Co., Ltd.
Decision Date2021-06-03
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Allmed Surgical Face Masks (Ear loops) is the device name listed in this FDA 510(k) record. The listed applicant is Allmed Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-06-03 under 510(k) number K202128. 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 Allmed Surgical Face Masks (Ear loops)?

Allmed Surgical Face Masks (Ear loops) is a medical device that received FDA 510(k) clearance on 2021-06-03. The listed applicant is Allmed Medical Products Co., Ltd.. The 510(k) number is K202128.

When did Allmed Surgical Face Masks (Ear loops) receive FDA 510(k) clearance?

Allmed Surgical Face Masks (Ear loops) received FDA 510(k) clearance on 2021-06-03, under 510(k) number K202128.

Who is the listed applicant for Allmed Surgical Face Masks (Ear loops)?

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

What is the FDA product code for Allmed Surgical Face Masks (Ear loops)?

The FDA product code for Allmed Surgical Face Masks (Ear loops) is FXX.

Other records listing Allmed Medical Products Co., Ltd. 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.

K221570Antibacterial bandageK202411Surgical MaskK202409Surgical 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

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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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