510(k) K030228
K030228 is an FDA 510(k) premarket notification submitted by Pt. Medisafe Technologies for the device "POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES". The FDA issued a decision of Substantially Equivalent on Mar 14, 2003. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Pt. Medisafe Technologies has 18 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 14, 2003
- Date Received
- Jan 22, 2003
- 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.