SUPERGLOVES

Latex Patient Examination Glove

SUPERMAX SDN BHD

The following data is part of a premarket notification filed by Supermax Sdn Bhd with the FDA for Supergloves.

Pre-market Notification Details

• Device ID: K980494
• 510k Number: K980494
• Device Name: SUPERGLOVES
• Classification: Latex Patient Examination Glove
• Applicant: SUPERMAX SDN BHD LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA Sungai Pelong, Selangor, MY 47500
• Contact: Stanley Thai
• Correspondent: Stanley Thai; SUPERMAX SDN BHD LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA Sungai Pelong, Selangor, MY 47500
• Product Code: LYY
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-02-09
• Decision Date: 1998-06-09