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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
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

MDR Year MDR Reports MDR Events
2019 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 1 1
Device Damaged Prior to Use 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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