FDA 510(k)

3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask

K-Number: K191355 · 2019-09-11

Decision Date2019-09-11

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask is a medical device manufactured by 3M Healthcare. It received FDA 510(k) clearance on 2019-09-11 under approval number K191355. 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 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask?

3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask is a medical device that received FDA 510(k) clearance on 2019-09-11. It is manufactured by 3M Healthcare. The 510(k) number is K191355.

When was 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask approved by the FDA?

3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask received FDA 510(k) clearance on 2019-09-11, under approval number K191355.

What company makes 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask?

3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask is manufactured by 3M Healthcare.

What is the FDA product code for 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask?

The FDA product code for 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask is FXX.

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Related PubMed Literature

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Other Devices by 3M Healthcare

K153571Cavilon Advanced High Endurance Skin Protectant K1711163M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S K1808743M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield K1804043M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System K1931103M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

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.