510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OPHClass I

Radiation Attenuating Medical Glove

21 CFR 880.6250 / General Hospital
FDA source (opens on fda.gov)

OPH is the FDA product code for Radiation Attenuating Medical Glove, a class I device type, regulated under 21 CFR 880.6250. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OPH
Device name
Radiation Attenuating Medical Glove
FDA 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.
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

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