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FDA 510(k)

Surgical Face Masks (Ear loops and Tie-on)

K-Number: K160269 · 2016-09-06

ApplicantSan-M Package Co., Ltd.
Decision Date2016-09-06
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Face Masks (Ear loops and Tie-on) is a medical device manufactured by San-M Package Co., Ltd.. It received FDA 510(k) clearance on 2016-09-06 under approval number K160269. 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 Masks (Ear loops and Tie-on)?

Surgical Face Masks (Ear loops and Tie-on) is a medical device that received FDA 510(k) clearance on 2016-09-06. It is manufactured by San-M Package Co., Ltd.. The 510(k) number is K160269.

When was Surgical Face Masks (Ear loops and Tie-on) approved by the FDA?

Surgical Face Masks (Ear loops and Tie-on) received FDA 510(k) clearance on 2016-09-06, under approval number K160269.

What company makes Surgical Face Masks (Ear loops and Tie-on)?

Surgical Face Masks (Ear loops and Tie-on) is manufactured by San-M Package Co., Ltd..

What is the FDA product code for Surgical Face Masks (Ear loops and Tie-on)?

The FDA product code for Surgical Face Masks (Ear loops and Tie-on) is FXX.

Other Devices by San-M Package Co., Ltd.

K160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 K221534Surgical Face Masks (Ear Loops And Tie-On)

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC 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 K1808743M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield3M Healthcare

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.

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