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FDA 510(k)

Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs

K-Number: K230217 · 2023-05-13

ApplicantGrand Work Plastic Products Co., Ltd.
Decision Date2023-05-13
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs is a medical device manufactured by Grand Work Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2023-05-13 under approval number K230217. 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 Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs?

Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2023-05-13. It is manufactured by Grand Work Plastic Products Co., Ltd.. The 510(k) number is K230217.

When was Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs approved by the FDA?

Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2023-05-13, under approval number K230217.

What company makes Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs?

Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs is manufactured by Grand Work Plastic Products Co., Ltd..

What is the FDA product code for Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs?

The FDA product code for Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs is KGO.

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Other Devices by Grand Work Plastic Products Co., Ltd.

K222892Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs K213574Nitrile Vinyl Blend Powder Free Examination Gloves (Black) K220249Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue) K220250Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs K220240Vinyl Co-Polymer Powder-free Examination Gloves, Black K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs

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Related Devices (Code: KGO)

K160928Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)Hartalega Sdb. Bhd. K160974Gammex Cut-Resistant Glove LinerAnsell Healthcare Products, LLC K161008POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVEHartalega Sdn Bhd K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingCardinal Health, Inc. K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)Cardinal Health, Inc. K152428SensiCare PI Surgical GlovesMedline Industries, 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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