# K133684: Ultrablox

- Pathway: 510(k) (Traditional)
- Applicant: Bloxr Corporation
- Decided: Jan 13, 2014 after 42 days
- Product code: PDK (Cream For X-Ray Attenuation)
- Device class: 2
- Regulation: 21 CFR 892.6510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN120022 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN120022: X-Ray Attenuating Cream, Bloxr Corporation (2013). Our reading of the summary gave K123422, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN120022, X-Ray Attenuating Cream (Bloxr Corporation), granted May 9, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Indications for use
The UltraBLOX X-ray Attenuating Cream is 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. The UIb~aBLOX X-ray Attenuating Cream is intended to be used during medical procedures where 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. NOTE: For use with natural rubber latex and latex-free poly-isoprene Surgeon's Gloves only.

Source page: https://510kreport.com/device/K133684
Methodology: https://510kreport.com/methodology