Purism Disposable Surgical Mask
K-Number: K210856 · 2021-07-28
Decision Date2021-07-28
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Purism Disposable Surgical Mask is a medical device manufactured by Chuzhou Daddy'S Choice Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-07-28 under approval number K210856. 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 Purism Disposable Surgical Mask?
Purism Disposable Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-07-28. It is manufactured by Chuzhou Daddy'S Choice Science and Technology Co., Ltd.. The 510(k) number is K210856.
When was Purism Disposable Surgical Mask approved by the FDA?
Purism Disposable Surgical Mask received FDA 510(k) clearance on 2021-07-28, under approval number K210856.
What company makes Purism Disposable Surgical Mask?
Purism Disposable Surgical Mask is manufactured by Chuzhou Daddy'S Choice Science and Technology Co., Ltd..
What is the FDA product code for Purism Disposable Surgical Mask?
The FDA product code for Purism Disposable 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.