FDA 510(k)

CPL Surgical Face Mask

K-Number: K213136 · 2021-12-24

Decision Date2021-12-24

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CPL Surgical Face Mask is a medical device manufactured by Control Print Limited. It received FDA 510(k) clearance on 2021-12-24 under approval number K213136. 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 CPL Surgical Face Mask?

CPL Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-12-24. It is manufactured by Control Print Limited. The 510(k) number is K213136.

When was CPL Surgical Face Mask approved by the FDA?

CPL Surgical Face Mask received FDA 510(k) clearance on 2021-12-24, under approval number K213136.

What company makes CPL Surgical Face Mask?

CPL Surgical Face Mask is manufactured by Control Print Limited.

What is the FDA product code for CPL Surgical Face Mask?

The FDA product code for CPL 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.