Surgical Mask
K-Number: K211497 · 2021-07-28
ApplicantHoneywell Safety Products
Decision Date2021-07-28
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical Mask is a medical device manufactured by Honeywell Safety Products. It received FDA 510(k) clearance on 2021-07-28 under approval number K211497. 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 Surgical Mask?
Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-07-28. It is manufactured by Honeywell Safety Products. The 510(k) number is K211497.
When was Surgical Mask approved by the FDA?
Surgical Mask received FDA 510(k) clearance on 2021-07-28, under approval number K211497.
What company makes Surgical Mask?
Surgical Mask is manufactured by Honeywell Safety Products.
What is the FDA product code for Surgical Mask?
The FDA product code for Surgical Mask is FXX.
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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.