510(k) K162852
K162852 is an FDA 510(k) premarket notification submitted by Lucenxia Prescience AG for the device "Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove". The FDA issued a decision of Substantially Equivalent on Feb 8, 2017. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Lucenxia Prescience AG has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 8, 2017
- Date Received
- Oct 11, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Surgeon'S Gloves
- Device Class
- Class I
- Regulation Number
- 878.4460
- Review Panel
- HO
- Submission Type
- 510(k)
A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.