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FDA 510(k)

Natural Rubber Latex Ultrasound Transducer Probe Covers

K-Number: K213087 · 2022-06-07

ApplicantGlobal Protection Corp.
Decision Date2022-06-07
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Natural Rubber Latex Ultrasound Transducer Probe Covers is a medical device manufactured by Global Protection Corp.. It received FDA 510(k) clearance on 2022-06-07 under approval number K213087. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Natural Rubber Latex Ultrasound Transducer Probe Covers?

Natural Rubber Latex Ultrasound Transducer Probe Covers is a medical device that received FDA 510(k) clearance on 2022-06-07. It is manufactured by Global Protection Corp.. The 510(k) number is K213087.

When was Natural Rubber Latex Ultrasound Transducer Probe Covers approved by the FDA?

Natural Rubber Latex Ultrasound Transducer Probe Covers received FDA 510(k) clearance on 2022-06-07, under approval number K213087.

What company makes Natural Rubber Latex Ultrasound Transducer Probe Covers?

Natural Rubber Latex Ultrasound Transducer Probe Covers is manufactured by Global Protection Corp..

What is the FDA product code for Natural Rubber Latex Ultrasound Transducer Probe Covers?

The FDA product code for Natural Rubber Latex Ultrasound Transducer Probe Covers is ITX.

Related Clinical Trials

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Other Devices by Global Protection Corp.

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Related Devices (Code: ITX)

K152126UST-5550-R; UST-5536-R; L43KHitachi Aloka Medical America, Inc. K160806Verza Guidance SystemCIVCO Medical Instruments Co., Inc. K160414Precision Point Biopsy Needle GuideCorbin Clinical Resources, LLC K153212Sheathes Ultrasound Probe CoversSheathing Technologies, Inc. K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO rangeKoelis K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe ReprocessorCIVCO Medical Instruments Co., 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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