SENSITOUCH

Surgeon's Gloves

ANSELL INTL.

The following data is part of a premarket notification filed by Ansell Intl. with the FDA for Sensitouch.

Pre-market Notification Details

• Device ID: K904769
• 510k Number: K904769
• Device Name: SENSITOUCH
• Classification: Surgeon's Gloves
• Applicant: ANSELL INTL. LOT 80, AIR KEROH IND. EST. Melaka, MT 75150
• Contact: Paul Cacioli
• Correspondent: Paul Cacioli; ANSELL INTL. LOT 80, AIR KEROH IND. EST. Melaka, MT 75150
• Product Code: KGO
• CFR Regulation Number: 878.4460 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-10-22
• Decision Date: 1991-01-28