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FDA 510(k)

Surgical face mask (Model: Flat Ear Loop/CN102)

K-Number: K203534 · 2021-07-21

ApplicantCrown Name Disposable Hygiene Products Fty., Ltd.
Decision Date2021-07-21
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical face mask (Model: Flat Ear Loop/CN102) is the device name listed in this FDA 510(k) record. The listed applicant is Crown Name Disposable Hygiene Products Fty., Ltd.. It received FDA 510(k) clearance on 2021-07-21 under 510(k) number K203534. 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: Flat Ear Loop/CN102)?

Surgical face mask (Model: Flat Ear Loop/CN102) is a medical device that received FDA 510(k) clearance on 2021-07-21. The listed applicant is Crown Name Disposable Hygiene Products Fty., Ltd.. The 510(k) number is K203534.

When did Surgical face mask (Model: Flat Ear Loop/CN102) receive FDA 510(k) clearance?

Surgical face mask (Model: Flat Ear Loop/CN102) received FDA 510(k) clearance on 2021-07-21, under 510(k) number K203534.

Who is the listed applicant for Surgical face mask (Model: Flat Ear Loop/CN102)?

The FDA 510(k) record lists Crown Name Disposable Hygiene Products Fty., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical face mask (Model: Flat Ear Loop/CN102)?

The FDA product code for Surgical face mask (Model: Flat Ear Loop/CN102) is FXX.

Other records listing Crown Name Disposable Hygiene Products Fty., 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.

K212422Disposable Surgical Isolation Gown

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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