COMFIT

Latex Patient Examination Glove

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: K953590
• 510k Number: K953590
• Device Name: COMFIT
• Classification: Latex Patient Examination Glove
• Applicant: WEMBLEY RUBBER PRODUCTS (M) SDN BHD LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor, MY 43900
• Contact: Ong Ghee Chee
• Correspondent: Ong Ghee Chee; WEMBLEY RUBBER PRODUCTS (M) SDN BHD LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor, MY 43900
• Product Code: LYY
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-07-31
• Decision Date: 1996-06-27
• Summary: summary