510(k) K993450
K993450 is an FDA 510(k) premarket notification submitted by Fitco Dipped Products Pvt., Ltd. for the device "LATEX SURGICAL GLOVES, PRE-POWDERED". The FDA issued a decision of Substantially Equivalent on Dec 29, 1999. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Fitco Dipped Products Pvt., Ltd. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 29, 1999
- Date Received
- Oct 12, 1999
- 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.