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FDA 510(k)

Medical disposable face mask non sterile

K-Number: K202650 · 2021-03-24

ApplicantGuangdong Zhong Ling Industrial Group Co., Ltd.
Decision Date2021-03-24
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical disposable face mask non sterile is a medical device manufactured by Guangdong Zhong Ling Industrial Group Co., Ltd.. It received FDA 510(k) clearance on 2021-03-24 under approval number K202650. 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 disposable face mask non sterile?

Medical disposable face mask non sterile is a medical device that received FDA 510(k) clearance on 2021-03-24. It is manufactured by Guangdong Zhong Ling Industrial Group Co., Ltd.. The 510(k) number is K202650.

When was Medical disposable face mask non sterile approved by the FDA?

Medical disposable face mask non sterile received FDA 510(k) clearance on 2021-03-24, under approval number K202650.

What company makes Medical disposable face mask non sterile?

Medical disposable face mask non sterile is manufactured by Guangdong Zhong Ling Industrial Group Co., Ltd..

What is the FDA product code for Medical disposable face mask non sterile?

The FDA product code for Medical disposable face mask non sterile is FXX.

Related Clinical Trials

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Related PubMed Literature

PMID: 30016835 Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel. Final order. Federal register (2018)

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.

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