510(k) K992679
K992679 is an FDA 510(k) premarket notification submitted by Wear Safe Malaysia Sdn. Bhd. for the device "SURGEON POWDER-FREE GLOVES, LATEX, STERILE". The FDA issued a decision of Substantially Equivalent on Oct 21, 1999. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Wear Safe Malaysia Sdn. Bhd. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 21, 1999
- Date Received
- Aug 10, 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.