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FDA 510(k)

SensiCare PI and SensiCare PI Micro Surgical Gloves

K-Number: K193217 · 2020-04-06

ApplicantMedline Industries, Inc.
Decision Date2020-04-06
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SensiCare PI and SensiCare PI Micro Surgical Gloves is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2020-04-06 under approval number K193217. 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 SensiCare PI and SensiCare PI Micro Surgical Gloves?

SensiCare PI and SensiCare PI Micro Surgical Gloves is a medical device that received FDA 510(k) clearance on 2020-04-06. It is manufactured by Medline Industries, Inc.. The 510(k) number is K193217.

When was SensiCare PI and SensiCare PI Micro Surgical Gloves approved by the FDA?

SensiCare PI and SensiCare PI Micro Surgical Gloves received FDA 510(k) clearance on 2020-04-06, under approval number K193217.

What company makes SensiCare PI and SensiCare PI Micro Surgical Gloves?

SensiCare PI and SensiCare PI Micro Surgical Gloves is manufactured by Medline Industries, Inc..

What is the FDA product code for SensiCare PI and SensiCare PI Micro Surgical Gloves?

The FDA product code for SensiCare PI and SensiCare PI Micro Surgical Gloves is KGO.

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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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