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FDA 510(k)

Disposable Surgical Face Mask

K-Number: K210643 · 2021-08-04

ApplicantShandong Zhushi Pharmaceutical Group Co., Ltd.
Decision Date2021-08-04
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Zhushi Pharmaceutical Group Co., Ltd.. It received FDA 510(k) clearance on 2021-08-04 under 510(k) number K210643. 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 Disposable Surgical Face Mask?

Disposable Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-08-04. The listed applicant is Shandong Zhushi Pharmaceutical Group Co., Ltd.. The 510(k) number is K210643.

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

Disposable Surgical Face Mask received FDA 510(k) clearance on 2021-08-04, under 510(k) number K210643.

Who is the listed applicant for Disposable Surgical Face Mask?

The FDA 510(k) record lists Shandong Zhushi Pharmaceutical Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Surgical Face Mask?

The FDA product code for Disposable Surgical Face Mask is FXX.

Other records listing Shandong Zhushi Pharmaceutical Group 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.

K232475Disposable infusion set with needleK212033Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needleK210510Disposable Surgical GownK210409Disposable Surgical Face MaskK203454Infrared ThermometerK203436Disposable Nitrile Examination Gloves

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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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