SURE

Condom

PLEASURE LATEX PRODUCTS SDN. BHD.

The following data is part of a premarket notification filed by Pleasure Latex Products Sdn. Bhd. with the FDA for Sure.

Pre-market Notification Details

• Device ID: K982380
• 510k Number: K982380
• Device Name: SURE
• Classification: Condom
• Applicant: PLEASURE LATEX PRODUCTS SDN. BHD. LOT 1365, 17TH MILES, JALAN SUNGAI SEMBILANG Jeram, Selangor, MY 45800
• Contact: Chang Ah Kau
• Correspondent: Chang Ah Kau; PLEASURE LATEX PRODUCTS SDN. BHD. LOT 1365, 17TH MILES, JALAN SUNGAI SEMBILANG Jeram, Selangor, MY 45800
• Product Code: HIS
• CFR Regulation Number: 884.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-07-08
• Decision Date: 1999-02-26