COMFIT

Surgeon's Gloves

WEMBLEY RUBBER PRODUCTS (M) SDN BHD

The following data is part of a premarket notification filed by Wembley Rubber Products (m) Sdn Bhd with the FDA for Comfit.

Pre-market Notification Details

• Device ID: K935464
• 510k Number: K935464
• Device Name: COMFIT
• Classification: Surgeon's Gloves
• Applicant: WEMBLEY RUBBER PRODUCTS (M) SDN BHD PERU BANDAR BARU SALAK TINGGI 43900 SEPANG Selangor, Malaysia, MY
• Contact: Ong Ghee Chee
• Correspondent: Ong Ghee Chee; WEMBLEY RUBBER PRODUCTS (M) SDN BHD PERU BANDAR BARU SALAK TINGGI 43900 SEPANG Selangor, Malaysia, MY
• Product Code: KGO
• CFR Regulation Number: 878.4460 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-11-12
• Decision Date: 1994-05-09