21 CFR 892.6500 — Apron, Leaded
Radiology (RA) · Subpart G—Miscellaneous Devices · § 892.6500
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EAJ | Apron, Leaded | 1 | 6 | |
| EAK | Screen, Leaded, Operator Radiation Protector | 1 | 7 | |
| IWO | Apron, Protective | 1 | 1 | |
| IWP | Radiographic Protective Glove | 1 | 5 | |
| IWQ | Curtain, Protective, Radiographic | 1 | 3 | |
| IWR | Holder, Syringe, Lead | 1 | 4 | |
| IWS | Shield, Eye, Radiological | 1 | 6 | |
| IWT | Shield, Gonadal | 1 | 2 | |
| IWW | Shield, Vial | 1 | 1 | |
| IWX | Barrier, Control Panel, X-Ray, Movable | 1 | 3 | |
| KPY | Shield, Protective, Personnel | 1 | 25 |
