510(k) K230832
K230832 is an FDA 510(k) premarket notification submitted by The Egyptian Company For Medical & Electronic Industries for the device "Powdered Free Sterile Natural Rubber Latex Surgical Gloves". The FDA issued a decision of Substantially Equivalent on August 16, 2023. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2023
- Date Received
- March 27, 2023
- 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.