510(k) K920538
K920538 is an FDA 510(k) premarket notification submitted by Burkhart Roentgen Intl., Inc. for the device "PROTECTIVE RADIOGRAFIC GLOVE". The FDA issued a decision of Substantially Equivalent on May 29, 1992. The device falls under product code IWP (Radiographic Protective Glove), a Class I device regulated under 21 CFR 892.6500. Burkhart Roentgen Intl., Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 1992
- Date Received
- February 5, 1992
- 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. -