510(k) K032501
K032501 is an FDA 510(k) premarket notification submitted by Maxter Glove Manufacturing Sdn Bhd for the device "MAXTER STERILE POWDER FREE SURGICAL GLOVES". The FDA issued a decision of Substantially Equivalent on Oct 17, 2003. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Maxter Glove Manufacturing Sdn Bhd has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 17, 2003
- Date Received
- Aug 13, 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.