510(k) K864064
K864064 is an FDA 510(k) premarket notification submitted by Futuremed Div. of Future Impex Corp. for the device "LATEX SURGICAL GLOVES". The FDA issued a decision of Substantially Equivalent on October 30, 1986. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Futuremed Div. of Future Impex Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 1986
- Date Received
- October 20, 1986
- 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
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.