PROFEEL

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 Profeel.

Pre-market Notification Details

• Device ID: K951661
• 510k Number: K951661
• Device Name: PROFEEL
• Classification: Surgeon's Gloves
• Applicant: WEMBLEY RUBBER PRODUCTS (M) SDN BHD LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor, MY 43900
• Contact: Ong G Chee
• Correspondent: Ong G Chee; WEMBLEY RUBBER PRODUCTS (M) SDN BHD LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor, MY 43900
• Product Code: KGO
• CFR Regulation Number: 878.4460 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-04-10
• Decision Date: 1995-05-17