Medical gloves

Medical gloves are classified by the FDA as Class 1 Medical Device, under individual product codes depending on the actual product. Notwithstanding, they fall under Reserved Items and are subject to premarket notification of intent to market, unless exempted. Medical gloves will also have to comply with labeling requirements under 21 CFR 801.20 by September 2018, unless exempted (21 CFR 801.30).


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