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FDA 510(k)

Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove

K-Number: K201592 · 2021-09-26

Decision Date2021-09-26
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health200, LLC. It received FDA 510(k) clearance on 2021-09-26 under 510(k) number K201592. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove?

Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove is a medical device that received FDA 510(k) clearance on 2021-09-26. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K201592.

When did Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove receive FDA 510(k) clearance?

Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove received FDA 510(k) clearance on 2021-09-26, under 510(k) number K201592.

Who is the listed applicant for Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove?

The FDA 510(k) record lists Cardinal Health200, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove?

The FDA product code for Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove is KGO.

Other records listing Cardinal Health200, LLC 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.

View all 14 devices →

Related Devices (Code: KGO)

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.

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.