(a) Identification. A cream for x-ray attenuation is a sterile cream intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a glove on the hand, followed by donning a second glove. Cream for x-ray attenuation is intended to be used during medical procedures in which hands are necessarily exposed to radiation to offer some degree of protection from radiation exposure in the diagnostic imaging range of up to 130 kVp. This may include surgical procedures that require the use of fluoroscopy or radiography or other procedures. Cream for x-ray attenuation is not intended to be used in or adjacent to the primary x-ray beam or the transmitted beam and should not be used in lieu of a Radiographic Procedure Glove, which is used in radiography for those studies requiring the physician's hand or forearm be in the direct path of the primary x-ray beam.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Design verification and validation must include documentation of results from safety and effectiveness testing. The results from safety and effectiveness testing must include:

(i) Biocompatibility data consistent with the intended use for the device;

(ii) Sterilization, packaging, and expiration date testing; and

(iii) Nonclinical and/or clinical performance testing representative of “as use” conditions demonstrating:

(A) Compatibility to the type(s) of surgical glove (e.g., latex, nitrile, vinyl) to be used with the device;

(B) Attenuation performance; and

(C) Proper application of the device.

(2) Labeling must include:

(i) A statement that the device is sterile and an expiration date.

(ii) A boxed warning statement prominently placed in all labeling material for these devices. That boxed warning statement must read: “The device is not intended to be used in or adjacent to the primary X-ray beam or transmitted beam and should not be used in lieu of a Radiographic Procedure Glove, which is used in radiography for those studies requiring the physician's hand or forearm be in the direct path of the primary X-ray beam.”

(iii) The methods and results from nonclinical and/or clinical performance testing representative of “as use” conditions demonstrating the amount of attenuation the device provides to the end user at 60, 80, 100, and 120 kVp.

(iv) Validated instructions for use for device application and a statement of how often the device must be removed and reapplied for effective shielding.

(v) Identification of the type(s) of surgical glove (e.g., latex, nitrile, vinyl) that is compatible for use with the device.