510(k) K983240
K983240 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Medical, Div. of Ethicon, Inc. for the device "NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES". The FDA issued a decision of Substantially Equivalent on November 30, 1998. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Johnson & Johnson Medical, Div. of Ethicon, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 1998
- Date Received
- September 15, 1998
- 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.