Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
K-Number: K201592 · 2021-09-26
ApplicantCardinal Health200, LLC
Decision Date2021-09-26
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove is a medical device manufactured by Cardinal Health200, LLC. It received FDA 510(k) clearance on 2021-09-26 under approval 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. It is manufactured by Cardinal Health200, LLC. The 510(k) number is K201592.
When was Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove approved by the FDA?
Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove received FDA 510(k) clearance on 2021-09-26, under approval number K201592.
What company makes Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove?
Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove is manufactured by Cardinal Health200, LLC.
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.
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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.