Ocean Pacific NeoNatural 1228-E

GUDID 20686864056083

Ocean Pacific NeoNatural - Polychloroprene Medical Examination Gloves - Chemotherapy Tested - Textured Fingertips - Powder Free - Non-Sterile - Chemical Resistant Emerald - X-Large

AMD Medicom Inc

Polychloroprene examination/treatment glove, non-powdered

• Primary Device ID: 20686864056083
• NIH Device Record Key: 6ef6bf55-a556-477b-a44c-66e28b9157fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ocean Pacific NeoNatural
• Version Model Number: 1228-E
• Catalog Number: 1228-E
• Company DUNS: 256880576
• Company Name: AMD Medicom 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40°C/104°F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00686864056089 [Unit of Use]
GS1	10686864056086 [Primary]
GS1	20686864056083 [Package]; Contains: 10686864056086; Package: Outer case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040607
• Premarket Notification: K981064

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: 2022-07-06
• Device Publish Date: 2022-06-28

On-Brand Devices [Ocean Pacific NeoNatural]

• 00686864059561: Ocean Pacific NeoNatural - Polychloroprene Medical Examination Gloves - Chemotherapy Tested - Te
• 20686864056083: Ocean Pacific NeoNatural - Polychloroprene Medical Examination Gloves - Chemotherapy Tested - Te
• 20686864056076: Ocean Pacific NeoNatural - Polychloroprene Medical Examination Gloves - Chemotherapy Tested - Te
• 20686864056069: Ocean Pacific NeoNatural - Polychloroprene Medical Examination Gloves - Chemotherapy Tested - Te
• 20686864056052: Ocean Pacific NeoNatural - Polychloroprene Medical Examination Gloves - Chemotherapy Tested - Te
• 20686864056045: Ocean Pacific NeoNatural - Polychloroprene Medical Examination Gloves - Chemotherapy Tested - Te