FDA 510(k)

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))

K-Number: K212460 · 2021-11-05

ApplicantGuangzhou Zhengkang Medical Equipment Co.,Ltd

Decision Date2021-11-05

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) is a medical device manufactured by Guangzhou Zhengkang Medical Equipment Co.,Ltd. It received FDA 510(k) clearance on 2021-11-05 under approval number K212460. 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 Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))?

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) is a medical device that received FDA 510(k) clearance on 2021-11-05. It is manufactured by Guangzhou Zhengkang Medical Equipment Co.,Ltd. The 510(k) number is K212460.

When was Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) approved by the FDA?

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) received FDA 510(k) clearance on 2021-11-05, under approval number K212460.

What company makes Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))?

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) is manufactured by Guangzhou Zhengkang Medical Equipment Co.,Ltd.

What is the FDA product code for Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))?

The FDA product code for Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) is FXX.

Related Clinical Trials

NCT04235764 En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device RECRUITING NCT07607860 Clinical Evaluation of the Adaptilens Accommodating IOL NOT_YET_RECRUITING NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING NCT07470411 Safety and Feasibility of the MACS in Surgical Procedures: A Prospective Multi-Center Study RECRUITING

Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (2026) PMID: 41831468 Cardiometabolic prediction models for young people with psychosis spectrum disorders in the UK (PsyMetRiC 2.0): a retrospective, multicohort clinical prediction model study. The lancet. Psychiatry (2026)

Other Devices by Guangzhou Zhengkang Medical Equipment Co.,Ltd

K222204Medical Surgical Mask

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.