510(k) K991940
K991940 is an FDA 510(k) premarket notification submitted by Brightway Holdings Sdn. Bhd. for the device "BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)". The FDA issued a decision of Substantially Equivalent on Jul 12, 1999. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Brightway Holdings Sdn. Bhd. has 23 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 12, 1999
- Date Received
- Jun 9, 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.