PREMIER

Latex Patient Examination Glove

PREMIER MEDICAL INDUSTRIES, INC.

The following data is part of a premarket notification filed by Premier Medical Industries, Inc. with the FDA for Premier.

Pre-market Notification Details

• Device ID: K942437
• 510k Number: K942437
• Device Name: PREMIER
• Classification: Latex Patient Examination Glove
• Applicant: PREMIER MEDICAL INDUSTRIES, INC. 801 FORESTWOOD DR. Romeoville, IL 60441
• Contact: Dan Kennison
• Correspondent: Dan Kennison; PREMIER MEDICAL INDUSTRIES, INC. 801 FORESTWOOD DR. Romeoville, IL 60441
• Product Code: LYY
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-05-20
• Decision Date: 1994-06-15