Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Disposable Surgical Mask (non sterile)

K-Number: K211451 · 2021-08-25

ApplicantQinhuangdao Taizhi Medical Technology Co., Ltd.
Decision Date2021-08-25
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Surgical Mask (non sterile) is a medical device manufactured by Qinhuangdao Taizhi Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-25 under approval number K211451. 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 Mask (non sterile)?

Disposable Surgical Mask (non sterile) is a medical device that received FDA 510(k) clearance on 2021-08-25. It is manufactured by Qinhuangdao Taizhi Medical Technology Co., Ltd.. The 510(k) number is K211451.

When was Disposable Surgical Mask (non sterile) approved by the FDA?

Disposable Surgical Mask (non sterile) received FDA 510(k) clearance on 2021-08-25, under approval number K211451.

What company makes Disposable Surgical Mask (non sterile)?

Disposable Surgical Mask (non sterile) is manufactured by Qinhuangdao Taizhi Medical Technology Co., Ltd..

What is the FDA product code for Disposable Surgical Mask (non sterile)?

The FDA product code for Disposable Surgical Mask (non sterile) is FXX.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07529444 Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants RECRUITING

Other Devices by Qinhuangdao Taizhi Medical Technology Co., Ltd.

K212205Medical Protective Masks K223686Medical Protective Masks

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

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.

↑