Surgical Face Mask
K-Number: K210518 · 2021-06-14
Decision Date2021-06-14
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical Face Mask is a medical device manufactured by Shandong Haidike Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-06-14 under approval number K210518. 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 Face Mask?
Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-06-14. It is manufactured by Shandong Haidike Medical Products Co., Ltd.. The 510(k) number is K210518.
When was Surgical Face Mask approved by the FDA?
Surgical Face Mask received FDA 510(k) clearance on 2021-06-14, under approval number K210518.
What company makes Surgical Face Mask?
Surgical Face Mask is manufactured by Shandong Haidike Medical Products Co., Ltd..
What is the FDA product code for Surgical Face Mask?
The FDA product code for Surgical Face Mask is FXX.
Other Devices by Shandong Haidike Medical Products Co., Ltd.
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.