FDA 510(k)

Sterile Polyisoprene Powder Free Surgical Gloves

K-Number: K171047 · 2017-06-22

ApplicantBetter Care Plastic Technology Co., Ltd.

Decision Date2017-06-22

Product CodeKGO

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Sterile Polyisoprene Powder Free Surgical Gloves is a medical device manufactured by Better Care Plastic Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-06-22 under approval number K171047. 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 Gloves?

Sterile Polyisoprene Powder Free Surgical Gloves is a medical device that received FDA 510(k) clearance on 2017-06-22. It is manufactured by Better Care Plastic Technology Co., Ltd.. The 510(k) number is K171047.

When was Sterile Polyisoprene Powder Free Surgical Gloves approved by the FDA?

Sterile Polyisoprene Powder Free Surgical Gloves received FDA 510(k) clearance on 2017-06-22, under approval number K171047.

What company makes Sterile Polyisoprene Powder Free Surgical Gloves?

Sterile Polyisoprene Powder Free Surgical Gloves is manufactured by Better Care Plastic Technology Co., Ltd..

What is the FDA product code for Sterile Polyisoprene Powder Free Surgical Gloves?

The FDA product code for Sterile Polyisoprene Powder Free Surgical Gloves is KGO.

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Other Devices by Better Care Plastic Technology Co., Ltd.

K171898Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs K182600Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) K222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) K221269Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K232266Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K232070Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.