SAFESKIN

Latex Patient Examination Glove

SAFESKIN CORP.

The following data is part of a premarket notification filed by Safeskin Corp. with the FDA for Safeskin.

Pre-market Notification Details

• Device ID: K952793
• 510k Number: K952793
• Device Name: SAFESKIN
• Classification: Latex Patient Examination Glove
• Applicant: SAFESKIN CORP. 6815 FLANDERS DRIVE, STE.150 San Diego, CA 92121
• Contact: Wava Truscott
• Correspondent: Wava Truscott; SAFESKIN CORP. 6815 FLANDERS DRIVE, STE.150 San Diego, CA 92121
• Product Code: LYY
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-06-19
• Decision Date: 1995-08-11