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FDA 510(k)

Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP

K-Number: K220749 · 2022-05-13

ApplicantUnimax Medical Products Co., Ltd.
Decision Date2022-05-13
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP is the device name listed in this FDA 510(k) record. The listed applicant is Unimax Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K220749. 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 Face Mask, Model Number-17.5X9.5CM EAR-LOOP?

Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Unimax Medical Products Co., Ltd.. The 510(k) number is K220749.

When did Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP receive FDA 510(k) clearance?

Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP received FDA 510(k) clearance on 2022-05-13, under 510(k) number K220749.

Who is the listed applicant for Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP?

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

What is the FDA product code for Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP?

The FDA product code for Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP is FXX.

Related Clinical Trials

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.

NCT07723430Comparison of High-Flow Nasal Cannula and Tight Face Mask for Maintaining Oxygenation During Rapid Sequence InductionNOT_YET_RECRUITING

Other records listing Unimax 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.

K221717Disposable Surgical Gown UM-148

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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