FDA 510(k)

Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs

K-Number: K200915 · 2021-07-09

Decision Date2021-07-09

Product CodeKGO

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs is a medical device manufactured by Gx Corporation Sdn Bhd. It received FDA 510(k) clearance on 2021-07-09 under approval number K200915. 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 Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs?

Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2021-07-09. It is manufactured by Gx Corporation Sdn Bhd. The 510(k) number is K200915.

When was Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs approved by the FDA?

Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs received FDA 510(k) clearance on 2021-07-09, under approval number K200915.

What company makes Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs?

Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs is manufactured by Gx Corporation Sdn Bhd.

What is the FDA product code for Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs?

The FDA product code for Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs is KGO.

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Other Devices by Gx Corporation Sdn Bhd

K183354Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate

Related Devices (Code: KGO)

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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.