ARSOFT

Polymer Patient Examination Glove

ALLIANCE RUBBER PRODUCTS SDN. BHD.

The following data is part of a premarket notification filed by Alliance Rubber Products Sdn. Bhd. with the FDA for Arsoft.

Pre-market Notification Details

• Device ID: K983146
• 510k Number: K983146
• Device Name: ARSOFT
• Classification: Polymer Patient Examination Glove
• Applicant: ALLIANCE RUBBER PRODUCTS SDN. BHD. PERINDUSTRIAN BUKIT PANCHOR 14300 NIBONG TEBAL Pulau Pinang, MY 52446-u
• Contact: Chua Hooi Koon
• Correspondent: Chua Hooi Koon; ALLIANCE RUBBER PRODUCTS SDN. BHD. PERINDUSTRIAN BUKIT PANCHOR 14300 NIBONG TEBAL Pulau Pinang, MY 52446-u
• Product Code: LZA
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-09-08
• Decision Date: 1998-12-07