POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE

Polymer Patient Examination Glove

GX CORPORATION SDN BHD

The following data is part of a premarket notification filed by Gx Corporation Sdn Bhd with the FDA for Powder Free Nitrile Examination Glove, Orange.

Pre-market Notification Details

• Device ID: K080937
• 510k Number: K080937
• Device Name: POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE
• Classification: Polymer Patient Examination Glove
• Applicant: GX CORPORATION SDN BHD LOT 6487A, BATU 5 3/4, SEMENTA JALAN KAPAR Klang, MY 42100
• Contact: Foo K Pu
• Correspondent: Foo K Pu; GX CORPORATION SDN BHD LOT 6487A, BATU 5 3/4, SEMENTA JALAN KAPAR Klang, MY 42100
• Product Code: LZA
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-04-02
• Decision Date: 2008-05-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30851253007190	K080937	000
30851253007183	K080937	000
30851253007176	K080937	000
30851253007169	K080937	000