FDA 510(k)

SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)

K-Number: K203538 · 2021-08-02

Decision Date2021-08-02

Product CodeKGO

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2021-08-02 under approval number K203538. 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 Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)?

SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2021-08-02. It is manufactured by Medline Industries, Inc.. The 510(k) number is K203538.

When was SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) approved by the FDA?

SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2021-08-02, under approval number K203538.

What company makes SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)?

SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) is manufactured by Medline Industries, Inc..

What is the FDA product code for SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)?

The FDA product code for SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) is KGO.

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Related PubMed Literature

PMID: 29602568 Evaluation of Ophthalmic Surgical Instrument Sterility Using Short-Cycle Sterilization for Sequential Same-Day Use. Ophthalmology (2018)

Other Devices by Medline Industries, Inc.

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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.