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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 the device name listed in this FDA 510(k) record. The listed applicant is B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.. It received FDA 510(k) clearance on 2021-01-12 under 510(k) 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. The listed applicant is B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.. The 510(k) number is K202843.

When did Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) receive FDA 510(k) clearance?

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

Who is the listed applicant for Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)?

The FDA 510(k) record lists B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: FXX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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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