Singapore’s Aspen Glove Gets 510(k) Clearance for Examination Gloves
Malaysia-based Aspen Glove has received 510(k) clearance from the FDA for its latex powder-free, examination-grade gloves.
On Jan. 15, five days before the end of the previous administration, the FDA issued a draft rule saying that such medical gloves would not need 510(k) clearances, but the agency reversed that policy in an April 16 notice.
The final rule required 510(k) marketing clearance for seven types of medical gloves classified as “reserved” Class I devices. The agency exempts almost all class I devices from premarket notification except for those classified as reserved.