
Burkhart Roentgen Intl., Inc.
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PROTECTIVE RADIOGRAFIC GLOVE is an FDA 510(k)-cleared medical device (K920538) manufactured by Burkhart Roentgen Intl., Inc.. This device is classified under the Radiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 28, 1992. Regulation: 8.

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