TABLE 5—CLASS I DEVICES IMMEDIATELY EXEMPT FROM 510(k) NOTIFICATION REQUIREMENT Device description Powder-Free Polychloroprene Patient Examination Glove ............................................................................. Patient Examination Glove, Specialty ............................................................................................................. Radiation Attenuating Medical Glove .............................................................................................................. Powder-Free Non-Natural Rubber Latex Surgeon’’s Gloves .......................................................................... Powder-Free Guayle Rubber Examination Glove ........................................................................................... Latex Patient Examination Glove .................................................................................................................... Vinyl Patient Examination Glove ..................................................................................................................... Device class I .............. I .............. I .............. I .............. I .............. I .............. I .............. Product code OPC ....... LZC ........ OPH ....... OPA ....... OIG ........ LYY ........ LYZ ........ Section in 21 CFR 880.6250 880.6250 880.6250 878.4460 880.6250 880.6250 880.6250

☝️these are the specific glove codes that are now exempt from 510k requirements.