Recently exempted Class I Devices from 510(k) Requirement

As per the new federal register notice surgeon’s and patient examination gloves including the below seven devices require FDA 510K Clearance.

Device description

Device class

Device code

Powder-Free Polychloroprene Patient Examination Glove

Class I

OPC

Patient Examination Glove, Specialty

Class I

LZC

Radiation Attenuating Medical Glove

Class I

OPH

Powder-Free Non-Natural Rubber Latex Surgeons Gloves

Class I

OPA

Powder-Free Guayle Rubber Examination Glove

Class I

OIG

Latex Patient Examination Glove

Class I

LYY

Vinyl Patient Examination Glove

Class I

LYZ

FDA publish all 510k clearance on fda website, you can find substantial equivalence letter at www.fda.gov. Below are examples of examination and surgical glove 510k clearance letter

Quick links