NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)

Polymer Patient Examination Glove

INNOVATIVE GLOVES CO; LTD

The following data is part of a premarket notification filed by Innovative Gloves Co; Ltd with the FDA for Nitrile Examination Gloves Polymer Coated (white, Blue, And Black Color).

Pre-market Notification Details

• Device ID: K103670
• 510k Number: K103670
• Device Name: NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)
• Classification: Polymer Patient Examination Glove
• Applicant: INNOVATIVE GLOVES CO; LTD 800 MOO 4,SAAMBIN-BAN KLANG RD KUANLANG Hatyai, Songkhla, TH 90110
• Contact: Rajeev Sood
• Correspondent: Rajeev Sood; INNOVATIVE GLOVES CO; LTD 800 MOO 4,SAAMBIN-BAN KLANG RD KUANLANG Hatyai, Songkhla, TH 90110
• Product Code: LZA
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-12-16
• Decision Date: 2011-03-31

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00759326041340	K103670	000
00759326941237	K103670	000
00759326041326	K103670	000