Nordiwell Surprotect Face Mask
K-Number: K210445 · 2021-06-29
Decision Date2021-06-29
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Nordiwell Surprotect Face Mask is a medical device manufactured by Changzhou Combat Protective Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-06-29 under approval number K210445. 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 Nordiwell Surprotect Face Mask?
Nordiwell Surprotect Face Mask is a medical device that received FDA 510(k) clearance on 2021-06-29. It is manufactured by Changzhou Combat Protective Equipment Co., Ltd.. The 510(k) number is K210445.
When was Nordiwell Surprotect Face Mask approved by the FDA?
Nordiwell Surprotect Face Mask received FDA 510(k) clearance on 2021-06-29, under approval number K210445.
What company makes Nordiwell Surprotect Face Mask?
Nordiwell Surprotect Face Mask is manufactured by Changzhou Combat Protective Equipment Co., Ltd..
What is the FDA product code for Nordiwell Surprotect Face Mask?
The FDA product code for Nordiwell Surprotect Face Mask is FXX.
Other Devices by Changzhou Combat Protective Equipment 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.