Disposable Surgical Face Mask
K-Number: K203380 · 2023-01-06
Decision Date2023-01-06
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Disposable Surgical Face Mask is a medical device manufactured by Shandong Pop Jeans Intelligent Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2023-01-06 under approval number K203380. 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 Face Mask?
Disposable Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2023-01-06. It is manufactured by Shandong Pop Jeans Intelligent Manufacturing Co., Ltd.. The 510(k) number is K203380.
When was Disposable Surgical Face Mask approved by the FDA?
Disposable Surgical Face Mask received FDA 510(k) clearance on 2023-01-06, under approval number K203380.
What company makes Disposable Surgical Face Mask?
Disposable Surgical Face Mask is manufactured by Shandong Pop Jeans Intelligent Manufacturing Co., Ltd..
What is the FDA product code for Disposable Surgical Face Mask?
The FDA product code for Disposable Surgical Face Mask is FXX.
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K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd.
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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.