510(k) K160781
K160781 is an FDA 510(k) premarket notification submitted by Semperit Investments Asia Pte , Ltd. for the device "Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves". The FDA issued a decision of Substantially Equivalent on May 2, 2017. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Semperit Investments Asia Pte , Ltd. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2017
- Date Received
- Mar 22, 2016
- 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.