Seven Types of Medical Gloves Will Continue to Need 510(k) Clearance, FDA Says

July 27, 2021

Seven types of medical gloves classified as Class I reserved devices require a 510(k) marketing clearance, the FDA said in a final rule.

On Jan. 15, five days before the end of the previous administration, HHS and the FDA had issued a draft rule saying that these types of medical gloves would not need 510(k) clearances, but they later reversed that policy in an April 16 notice.

“Based on the risks inherent to surgeon's gloves and patient examination gloves and the diseases being prevented, FDA's experience with these devices, and other relevant considerations,” gloves with the product codes LYY, LYZ, OIG, OPC, OPH, LZC, and OPA will continue to require a 510(k) clearance, the agency said.

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