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FDA 510(k)

Medical Surgical Mask-Model MP002-5, MP002-6

K-Number: K202577 · 2021-01-11

ApplicantJiangmen Sure&Me Medical Product Co., Ltd.
Decision Date2021-01-11
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Surgical Mask-Model MP002-5, MP002-6 is a medical device manufactured by Jiangmen Sure&Me Medical Product Co., Ltd.. It received FDA 510(k) clearance on 2021-01-11 under approval number K202577. 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 MP002-5, MP002-6?

Medical Surgical Mask-Model MP002-5, MP002-6 is a medical device that received FDA 510(k) clearance on 2021-01-11. It is manufactured by Jiangmen Sure&Me Medical Product Co., Ltd.. The 510(k) number is K202577.

When was Medical Surgical Mask-Model MP002-5, MP002-6 approved by the FDA?

Medical Surgical Mask-Model MP002-5, MP002-6 received FDA 510(k) clearance on 2021-01-11, under approval number K202577.

What company makes Medical Surgical Mask-Model MP002-5, MP002-6?

Medical Surgical Mask-Model MP002-5, MP002-6 is manufactured by Jiangmen Sure&Me Medical Product Co., Ltd..

What is the FDA product code for Medical Surgical Mask-Model MP002-5, MP002-6?

The FDA product code for Medical Surgical Mask-Model MP002-5, MP002-6 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)

Related Devices (Code: FXX)

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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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