POLY-MED

Latex Patient Examination Glove

SHINEMOUND ENTERPRISE, INC.

The following data is part of a premarket notification filed by Shinemound Enterprise, Inc. with the FDA for Poly-med.

Pre-market Notification Details

• Device ID: K970625
• 510k Number: K970625
• Device Name: POLY-MED
• Classification: Latex Patient Examination Glove
• Applicant: SHINEMOUND ENTERPRISE, INC. 34 LINNELL CIRCLE Billerica, MA 01821
• Contact: Huan-chung Li
• Correspondent: Huan-chung Li; SHINEMOUND ENTERPRISE, INC. 34 LINNELL CIRCLE Billerica, MA 01821
• Product Code: LYY
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-02-19
• Decision Date: 1997-03-27