510(k) K904878
K904878 is an FDA 510(k) premarket notification submitted by Hpi, Inc. for the device "SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.". The FDA issued a decision of Substantially Equivalent on March 7, 1991. The device falls under product code IWP (Radiographic Protective Glove), a Class I device regulated under 21 CFR 892.6500. Hpi, Inc. has at least 5 other 510(k) clearances on record.
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. -