FDA 510(k)

Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)

K-Number: K202843 · 2021-01-12

ApplicantB.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.

Decision Date2021-01-12

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) is a medical device manufactured by B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.. It received FDA 510(k) clearance on 2021-01-12 under approval number K202843. 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 (Sterile), Surgical Face Masks (Non-sterile)?

Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) is a medical device that received FDA 510(k) clearance on 2021-01-12. It is manufactured by B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.. The 510(k) number is K202843.

When was Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) approved by the FDA?

Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) received FDA 510(k) clearance on 2021-01-12, under approval number K202843.

What company makes Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)?

Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) is manufactured by B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd..

What is the FDA product code for Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)?

The FDA product code for Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) is FXX.

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Other Devices by B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.

K202706Surgical Gown (Sterile), Surgical Gown (Non-sterile)

Related Devices (Code: FXX)

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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.