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FDA 510(k)

Surgical Mask

K-Number: K210908 · 2021-09-26

ApplicantSichuan Prius Biotechnology Co., Ltd.
Decision Date2021-09-26
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Mask is a medical device manufactured by Sichuan Prius Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-26 under approval number K210908. 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 Mask?

Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-09-26. It is manufactured by Sichuan Prius Biotechnology Co., Ltd.. The 510(k) number is K210908.

When was Surgical Mask approved by the FDA?

Surgical Mask received FDA 510(k) clearance on 2021-09-26, under approval number K210908.

What company makes Surgical Mask?

Surgical Mask is manufactured by Sichuan Prius Biotechnology Co., Ltd..

What is the FDA product code for Surgical Mask?

The FDA product code for Surgical Mask is FXX.

Other Devices by Sichuan Prius Biotechnology Co., Ltd.

K221078Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use K221075Infusion Sets for Single Use K221069Infusion Sets for Single Use with Needles K221079Sterile Hypodermic Syringes for Single Use K221080Sterile Safety Hypodermic Needles for Single Use K221073Sterile Hypodermic Syringes for Single Use with Safety Needles

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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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