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FDA 510(k)

Medical Surgical Mask (Non-sterile)

K-Number: K202761 · 2021-04-11

ApplicantGuangdong Goodfeeling Hygiene Material Tec Co., Ltd.
Decision Date2021-04-11
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Surgical Mask (Non-sterile) is a medical device manufactured by Guangdong Goodfeeling Hygiene Material Tec Co., Ltd.. It received FDA 510(k) clearance on 2021-04-11 under approval number K202761. 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 (Non-sterile)?

Medical Surgical Mask (Non-sterile) is a medical device that received FDA 510(k) clearance on 2021-04-11. It is manufactured by Guangdong Goodfeeling Hygiene Material Tec Co., Ltd.. The 510(k) number is K202761.

When was Medical Surgical Mask (Non-sterile) approved by the FDA?

Medical Surgical Mask (Non-sterile) received FDA 510(k) clearance on 2021-04-11, under approval number K202761.

What company makes Medical Surgical Mask (Non-sterile)?

Medical Surgical Mask (Non-sterile) is manufactured by Guangdong Goodfeeling Hygiene Material Tec Co., Ltd..

What is the FDA product code for Medical Surgical Mask (Non-sterile)?

The FDA product code for Medical Surgical Mask (Non-sterile) is FXX.

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Related PubMed Literature

PMID: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (2026) PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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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