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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 the device name listed in this FDA 510(k) record. The listed applicant is Global Protection Corp.. It received FDA 510(k) clearance on 2022-06-07 under 510(k) 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. The listed applicant is Global Protection Corp.. The 510(k) number is K213087.

When did Natural Rubber Latex Ultrasound Transducer Probe Covers receive FDA 510(k) clearance?

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

Who is the listed applicant for Natural Rubber Latex Ultrasound Transducer Probe Covers?

The FDA 510(k) record lists Global Protection Corp. as the applicant. This does not by itself establish the device manufacturer.

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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NCT06557499A 3-way Crossover Clinical Investigation to Assess the Performance of Two Different Sized Polyurethane Condoms Versus a Latex Condom in Healthy Monogamous Couples.COMPLETED

Other records listing Global Protection Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: ITX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.K250883ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)Olympus Medical Systems Corporation

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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