IWP — Radiographic Protective Glove Class I
FDA product code IWP covers "Radiographic Protective Glove", a Class I medical device regulated under 21 CFR 892.6500. Submissions are reviewed by the Radiology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IWP
- Device Class
- Class I
- Regulation Number
- 892.6500
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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. -
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K920538 | burkhart roentgen intl | PROTECTIVE RADIOGRAFIC GLOVE | May 29, 1992 |
| K904878 | hpi | SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER. | March 7, 1991 |
| K905086 | hpi | HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES | December 3, 1990 |
| K900972 | infab | RADIATION PROTECTION GLOVES | May 1, 1990 |
| K844683 | boots-celltech diagnostics | IMAGEN CHLAMYDIA TEST | February 6, 1985 |