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FDA 510(k)

PROTECTIVE RADIOGRAFIC GLOVE

K-Number: K920538 · 1992-05-29

ApplicantBurkhart Roentgen Intl., Inc.
Decision Date1992-05-29
Product CodeIWP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROTECTIVE RADIOGRAFIC GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Burkhart Roentgen Intl., Inc.. It received FDA 510(k) clearance on 1992-05-29 under 510(k) number K920538. The device is classified under product code IWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTECTIVE RADIOGRAFIC GLOVE?

PROTECTIVE RADIOGRAFIC GLOVE is a medical device that received FDA 510(k) clearance on 1992-05-29. The listed applicant is Burkhart Roentgen Intl., Inc.. The 510(k) number is K920538.

When did PROTECTIVE RADIOGRAFIC GLOVE receive FDA 510(k) clearance?

PROTECTIVE RADIOGRAFIC GLOVE received FDA 510(k) clearance on 1992-05-29, under 510(k) number K920538.

Who is the listed applicant for PROTECTIVE RADIOGRAFIC GLOVE?

The FDA 510(k) record lists Burkhart Roentgen Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROTECTIVE RADIOGRAFIC GLOVE?

The FDA product code for PROTECTIVE RADIOGRAFIC GLOVE is IWP.

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Other records listing Burkhart Roentgen Intl., Inc. 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.

K920539ORWO X-RAY FILMK920540RADIOLOGICAL PROTECTIVE EYE SHIELD

Related Devices (Code: IWP)

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.

K904878SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.Hpi, Inc.K905086HPI TRI-RADS VINYL RADIATION PROTECTION GLOVESHpi, Inc.K900972RADIATION PROTECTION GLOVESInfab Corp.K844683IMAGEN CHLAMYDIA TESTBoots-Celltech Diagnostics, 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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