UNIGLOVES

Latex Patient Examination Glove

UNI-GLOVE (USA), INC.

The following data is part of a premarket notification filed by Uni-glove (usa), Inc. with the FDA for Unigloves.

Pre-market Notification Details

• Device ID: K971731
• 510k Number: K971731
• Device Name: UNIGLOVES
• Classification: Latex Patient Examination Glove
• Applicant: UNI-GLOVE (USA), INC. 2420 CARSON ST., SUITE 125 Torrance, CA 90501
• Contact: Robert D Vander Leek
• Correspondent: Robert D Vander Leek; UNI-GLOVE (USA), INC. 2420 CARSON ST., SUITE 125 Torrance, CA 90501
• Product Code: LYY
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-05-09
• Decision Date: 1997-08-05