REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE

Latex Patient Examination Glove

LONDON INTERNATIONAL GROUP, INC.

The following data is part of a premarket notification filed by London International Group, Inc. with the FDA for Regent Biogel Diagnostic Procedure Glove.

Pre-market Notification Details

• Device ID: K971514
• 510k Number: K971514
• Device Name: REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE
• Classification: Latex Patient Examination Glove
• Applicant: LONDON INTERNATIONAL GROUP, INC. 2926 COLUMBIA HIGHWAY P.O. BOX 8308 Dotham, AL 36303
• Contact: Neil Anderson
• Correspondent: Neil Anderson; LONDON INTERNATIONAL GROUP, INC. 2926 COLUMBIA HIGHWAY P.O. BOX 8308 Dotham, AL 36303
• Product Code: LYY
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-04-25
• Decision Date: 1997-10-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05060097937233	K971514	000
05060097937141	K971514	000
05060097937219	K971514	000
05060097937127	K971514	000
05060097937110	K971514	000
05060097937103	K971514	000
05060097937097	K971514	000
05060097937080	K971514	000