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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radiographic protective glove
Regulation Description Personnel protective shield.
Definition A protective radiographic glove is a "personnel protective shield." The gloves are intended to protect the operator, patient, or other person from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. Note: These devices are not patient examination gloves or surgeon's gloves. -
Product CodeIWP
Regulation Number 892.6500
Device Class 1