IWP · Radiographic Protective Glove
Radiology · 21 CFR 892.6500 · Class 1
Overview
| Product Code | IWP |
|---|---|
| Device Name | Radiographic Protective Glove |
| Regulation | 21 CFR 892.6500 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K920538 | PROTECTIVE RADIOGRAFIC GLOVE | Burkhart Roentgen Intl., Inc. | May 29, 1992 | SESE |
| K904878 | SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER. | Hpi, Inc. | Mar 7, 1991 | SESE |
| K905086 | HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES | Hpi, Inc. | Dec 3, 1990 | SESE |
| K900972 | RADIATION PROTECTION GLOVES | Infab Corp. | May 1, 1990 | SESE |
| K844683 | IMAGEN CHLAMYDIA TEST | Boots-Celltech Diagnostics, Inc. | Feb 6, 1985 | SESE |
Top Applicants
- Hpi, Inc. — 2 clearances
- Infab Corp. — 1 clearance
- Burkhart Roentgen Intl., Inc. — 1 clearance
- Boots-Celltech Diagnostics, Inc. — 1 clearance
