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FDA 510(k)

Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)

K-Number: K211827 · 2021-09-23

ApplicantZhejiang Lanhine Medical Products, Ltd.
Decision Date2021-09-23
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Lanhine Medical Products, Ltd.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K211827. 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 Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)?

Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Zhejiang Lanhine Medical Products, Ltd.. The 510(k) number is K211827.

When did Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) receive FDA 510(k) clearance?

Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) received FDA 510(k) clearance on 2021-09-23, under 510(k) number K211827.

Who is the listed applicant for Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)?

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

What is the FDA product code for Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)?

The FDA product code for Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) 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.

NCT07760129Erector Spinae Oxygen Saturation and AKI After OPCABNOT_YET_RECRUITINGNCT07646730Wearable Device-Based Early Warning of Postoperative Complications in Thoracic SurgeryRECRUITING

Other records listing Zhejiang Lanhine Medical Products, 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.

K211832Fluid Resistant Procedure Mask, Fluid Resistant Surgical 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

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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