BASIC

GUDID B845NGCM10433

Intco Medical Industries, Inc.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: B845NGCM10433
• NIH Device Record Key: 9fba733e-5abc-4b30-8cbc-14b8a44b26f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BASIC
• Version Model Number: NGCM1043
• Company DUNS: 080162537
• Company Name: Intco Medical Industries, Inc.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B845NGCM1043 [Unit of Use]
HIBCC	B845NGCM10431 [Primary]
HIBCC	B845NGCM10433 [Package]; Contains: B845NGCM10431; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123869
• Premarket Notification: K133307

FDA Product Code

• LZA: Polymer Patient Examination Glove

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-16
• Device Publish Date: 2023-06-08

On-Brand Devices [BASIC]

• B845VGPF30043: VGPF3004
• B845VGPF30033: VGPF3003
• B845VGPF30023: VGPF3002
• B845VGPF30013: VGPF3001
• B845VGPF30003: VGPF3000
• B845SMPF30043: SMPF3004
• B845SMPF30033: SMPF3003
• B845SMPF30023: SMPF3002
• B845SMPF30013: SMPF3001
• B845SGBE80043: SGBE8004
• B845SGBE80033: SGBE8003
• B845SGBE80023: SGBE8002
• B845SGBE80013: SGBE8001
• B845BMPF30043: BMPF3004
• B845BMPF30033: BMPF3003
• B845BMPF30023: BMPF3002
• B845BMPF30013: BMPF3001
• B845BMPF30003: BMPF3000
• B845NGVM10173: NGVM1017
• B845NGVM10163: NGVM1016
• B845NGVM10153: NGVM1015
• B845NGVM10143: NGVM1014
• B845NGVM10133: NGVM1013
• B845NGPM10183: NGPM1018
• B845NGPM10173: NGPM1017
• B845NGPM10163: NGPM1016
• B845NGPM10153: NGPM1015
• B845NGPM10143: NGPM1014
• B845NGPM10133: NGPM1013
• B845ICE106900: INSTANT COLD PACK
• B845ICE10560: INSTANT COLD PACK
• B845NGCM10483: NGCM1048
• B845NGCM10473: NGCM1047
• B845NGCM10463: NGCM1046
• B845NGCM10453: NGCM1045
• B845NGCM10443: NGCM1044
• B845NGCM10433: NGCM1043
• B845NGXM10483: NGXM1048
• B845NGXM10473: NGXM1047
• B845NGXM10463: NGXM1046
• B845NGXM10453: NGXM1045
• B845NGXM10443: NGXM1044
• B845NGXM10433: NGXM1043
• B845NGXM10183: NGXM1018
• B845NGXM10173: NGXM1017
• B845NGXM10163: NGXM1016
• B845NGXM10153: NGXM1015
• B845NGXM10143: NGXM1014
• B845NGXM10133: NGXM1013
• B845NGHM10483: NGHM1048