Disposable medical mask
K-Number: K202137 · 2021-03-04
ApplicantU-Play Products Corporation
Decision Date2021-03-04
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Disposable medical mask is a medical device manufactured by U-Play Products Corporation. It received FDA 510(k) clearance on 2021-03-04 under approval number K202137. 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 medical mask?
Disposable medical mask is a medical device that received FDA 510(k) clearance on 2021-03-04. It is manufactured by U-Play Products Corporation. The 510(k) number is K202137.
When was Disposable medical mask approved by the FDA?
Disposable medical mask received FDA 510(k) clearance on 2021-03-04, under approval number K202137.
What company makes Disposable medical mask?
Disposable medical mask is manufactured by U-Play Products Corporation.
What is the FDA product code for Disposable medical mask?
The FDA product code for Disposable medical mask is FXX.
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K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , 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.