WYZ Surgical Mask
K-Number: K211576 · 2021-08-19
ApplicantWyz Medical Supplies, LLC
Decision Date2021-08-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
WYZ Surgical Mask is a medical device manufactured by Wyz Medical Supplies, LLC. It received FDA 510(k) clearance on 2021-08-19 under approval number K211576. 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 WYZ Surgical Mask?
WYZ Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-08-19. It is manufactured by Wyz Medical Supplies, LLC. The 510(k) number is K211576.
When was WYZ Surgical Mask approved by the FDA?
WYZ Surgical Mask received FDA 510(k) clearance on 2021-08-19, under approval number K211576.
What company makes WYZ Surgical Mask?
WYZ Surgical Mask is manufactured by Wyz Medical Supplies, LLC.
What is the FDA product code for WYZ Surgical Mask?
The FDA product code for WYZ Surgical Mask is FXX.
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.