SYNTEX

Vinyl Patient Examination Glove

SHINEMOUND ENTERPRISE, INC.

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

Pre-market Notification Details

• Device ID: K971360
• 510k Number: K971360
• Device Name: SYNTEX
• Classification: Vinyl 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: LYZ
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-04-11
• Decision Date: 1997-12-22