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FDA 510(k)

Surgical Face Mask

K-Number: K202205 · 2021-03-09

ApplicantJiangsu Micsafe Medical Technology Co., Ltd.
Decision Date2021-03-09
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Face Mask is a medical device manufactured by Jiangsu Micsafe Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-03-09 under approval number K202205. 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 Mask?

Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-03-09. It is manufactured by Jiangsu Micsafe Medical Technology Co., Ltd.. The 510(k) number is K202205.

When was Surgical Face Mask approved by the FDA?

Surgical Face Mask received FDA 510(k) clearance on 2021-03-09, under approval number K202205.

What company makes Surgical Face Mask?

Surgical Face Mask is manufactured by Jiangsu Micsafe Medical Technology Co., Ltd..

What is the FDA product code for Surgical Face Mask?

The FDA product code for Surgical Face Mask is FXX.

Other Devices by Jiangsu Micsafe Medical Technology Co., Ltd.

K181426Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) K183665Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use K212019Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single K202570Insulin Syringe, Insulin Syringe with Safety Retractable

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.

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