510(k) K904878
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 1991
- Date Received
- October 30, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiographic Protective Glove
- Device Class
- Class I
- Regulation Number
- 892.6500
- Review Panel
- RA
- Submission Type
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. -