510(k) K972621
K972621 is an FDA 510(k) premarket notification submitted by Wembley Rubber Products (M) Sdn Bhd for the device "PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)". The FDA issued a decision of Substantially Equivalent on October 24, 1997. The device falls under product code KGO (Surgeon'S Gloves), a Class I device regulated under 21 CFR 878.4460. Wembley Rubber Products (M) Sdn Bhd has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 1997
- Date Received
- July 14, 1997
- 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.