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FDA 510(k)

ProGear® Surgical Mask with Oxafence®, Model AV82030

K-Number: K231741 · 2024-09-05

ApplicantPrestige Ameritech
Decision Date2024-09-05
Product CodeOUK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ProGear® Surgical Mask with Oxafence®, Model AV82030 is the device name listed in this FDA 510(k) record. The listed applicant is Prestige Ameritech. It received FDA 510(k) clearance on 2024-09-05 under 510(k) number K231741. The device is classified under product code OUK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProGear® Surgical Mask with Oxafence®, Model AV82030?

ProGear® Surgical Mask with Oxafence®, Model AV82030 is a medical device that received FDA 510(k) clearance on 2024-09-05. The listed applicant is Prestige Ameritech. The 510(k) number is K231741.

When did ProGear® Surgical Mask with Oxafence®, Model AV82030 receive FDA 510(k) clearance?

ProGear® Surgical Mask with Oxafence®, Model AV82030 received FDA 510(k) clearance on 2024-09-05, under 510(k) number K231741.

Who is the listed applicant for ProGear® Surgical Mask with Oxafence®, Model AV82030?

The FDA 510(k) record lists Prestige Ameritech as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProGear® Surgical Mask with Oxafence®, Model AV82030?

The FDA product code for ProGear® Surgical Mask with Oxafence®, Model AV82030 is OUK.

Other records listing Prestige Ameritech 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.

K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldK160100Prestige Ameritech Pediatric/Child’s Face maskK152561Communicator Surgical Facemask with Clear Window

Related Devices (Code: OUK)

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.

K192105Innonix Antiviral Child's Face MaskInnonix Technologies LimitedK182766Cufitec Surgical MaskNbc Meshtec, Inc.

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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