SAFESKIN

Polymer 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: K962139
• 510k Number: K962139
• Device Name: SAFESKIN
• Classification: Polymer Patient Examination Glove
• Applicant: SAFESKIN CORP. 12671 HIGH BLUFF DR. San Diego, CA 92130
• Contact: Michelle Molloy
• Correspondent: Michelle Molloy; SAFESKIN CORP. 12671 HIGH BLUFF DR. San Diego, CA 92130
• Product Code: LZA
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-06-03
• Decision Date: 1996-12-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10036000531043	K962139	000
30680651531019	K962139	000
30680651531026	K962139	000
30680651531033	K962139	000
30680651531040	K962139	000
10036000531005	K962139	000
10036000531012	K962139	000
10036000531029	K962139	000
10036000531036	K962139	000
30680651531002	K962139	000