Velguard Surgical Face Mask
K-Number: K210761 · 2021-07-16
ApplicantEsstee Exports Health Care Division
Decision Date2021-07-16
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Velguard Surgical Face Mask is a medical device manufactured by Esstee Exports Health Care Division. It received FDA 510(k) clearance on 2021-07-16 under approval number K210761. 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 Velguard Surgical Face Mask?
Velguard Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-07-16. It is manufactured by Esstee Exports Health Care Division. The 510(k) number is K210761.
When was Velguard Surgical Face Mask approved by the FDA?
Velguard Surgical Face Mask received FDA 510(k) clearance on 2021-07-16, under approval number K210761.
What company makes Velguard Surgical Face Mask?
Velguard Surgical Face Mask is manufactured by Esstee Exports Health Care Division.
What is the FDA product code for Velguard Surgical Face Mask?
The FDA product code for Velguard Surgical Face 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.