FDA product code OPH: Radiation Attenuating Medical Glove

OPH is the FDA product code for radiation attenuating medical glove. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel. Devices under OPH reach the market by 510(k); FDA lists no cleared 510(k)s for it.

Definition

Radiations attenuating medical gloves are medical gloves that are used during medical or surgical procedures involving radiation to shield the hands of the wearer from scattered radiation exposure. The gloves offer some degree of protection to the hand from radiation exposure as well as protection from transmission of infectious agents. The use of these gloves includes procedures that require the use of fluoroscopy or radiography. In addition to meeting the requirements for examination or surgeon¿s gloves, manufacturers should have technical data to show that their attenuation claims meet the energy range of x-rays normally used in medical procedures.

Classification

Recalls for OPH devices

openFDA lists no recalls for product code OPH.

Frequently asked questions

What is FDA product code OPH?

OPH is the FDA product code for radiation attenuating medical glove. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel.

What device class is OPH?

Class I, regulation 21 CFR 880.6250. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code OPH
• Run a recall and safety report across every OPH manufacturer
• Watch product code OPH for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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