FDA 510(k)

AllureTM Surgical Mask

Numéro K : K212926 · 2022-09-16

DemandeurAllure Gift Wraps Private Limited

Date de décision2022-09-16

Code produitFXX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

AllureTM Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Allure Gift Wraps Private Limited. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K212926. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the AllureTM Surgical Mask?

AllureTM Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Allure Gift Wraps Private Limited. The 510(k) number is K212926.

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

AllureTM Surgical Mask received FDA 510(k) clearance on 2022-09-16, under 510(k) number K212926.

Who is the listed applicant for AllureTM Surgical Mask?

The FDA 510(k) record lists Allure Gift Wraps Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AllureTM Surgical Mask?

The FDA product code for AllureTM Surgical Mask is FXX.

Essais cliniques associés

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Dispositifs connexes (Code : FXX)

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.

Source officielle

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