Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs
K-Number: K213289 · 2023-05-26
ApplicantAnsell Healthcare Products, LLC
Decision Date2023-05-26
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs is a medical device manufactured by Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2023-05-26 under approval number K213289. 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 Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs?
Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2023-05-26. It is manufactured by Ansell Healthcare Products, LLC. The 510(k) number is K213289.
When was Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs approved by the FDA?
Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs received FDA 510(k) clearance on 2023-05-26, under approval number K213289.
What company makes Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs?
Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs is manufactured by Ansell Healthcare Products, LLC.
What is the FDA product code for Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs?
The FDA product code for Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs 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.