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FDA 510(k)

Single-Use Surgical Mask

K-Number: K201924 · 2021-03-15

ApplicantQiqihar Hengxin Medical Supplies, Ltd.
Decision Date2021-03-15
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Single-Use Surgical Mask is a medical device manufactured by Qiqihar Hengxin Medical Supplies, Ltd.. It received FDA 510(k) clearance on 2021-03-15 under approval number K201924. 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 Single-Use Surgical Mask?

Single-Use Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-03-15. It is manufactured by Qiqihar Hengxin Medical Supplies, Ltd.. The 510(k) number is K201924.

When was Single-Use Surgical Mask approved by the FDA?

Single-Use Surgical Mask received FDA 510(k) clearance on 2021-03-15, under approval number K201924.

What company makes Single-Use Surgical Mask?

Single-Use Surgical Mask is manufactured by Qiqihar Hengxin Medical Supplies, Ltd..

What is the FDA product code for Single-Use Surgical Mask?

The FDA product code for Single-Use Surgical Mask is FXX.

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Other Devices by Qiqihar Hengxin Medical Supplies, Ltd.

K201691Single-Use Surgical Mask With Ear Loop

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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