POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR

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 Gloves, Blue, White, Pink, Black And Gray Color.

Pre-market Notification Details

• Device ID: K070096
• 510k Number: K070096
• Device Name: POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR
• Classification: Polymer Patient Examination Glove
• Applicant: GX CORPORATION SDN BHD LOT 6487, BATU 5 3/4, SEMENTA JALAN KAPAR Klang, MY 42100
• Contact: Foo Khon Pu
• Correspondent: Foo Khon Pu; GX CORPORATION SDN BHD LOT 6487, 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: 2007-01-10
• Decision Date: 2007-03-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30851253007398	K070096	000
30851253007381	K070096	000
30851253007374	K070096	000
30851253007367	K070096	000
30851253007152	K070096	000
30851253007145	K070096	000
30851253007138	K070096	000
30851253007121	K070096	000