510(k) K191860
K191860 is an FDA 510(k) premarket notification submitted by Semperit Technische Produkte Gesellchaft M.B.H. for the device "Sterile Powder-Free Synthetic Rubber Surgeons Glove with Low Dermatitis Potential". The FDA issued a decision of Substantially Equivalent on Mar 31, 2020. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 31, 2020
- Date Received
- Jul 11, 2019
- Clearance Type
- Abbreviated
- 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.