Ocean Pacific Elements OPBIO-SP6

GUDID 00686864060741

Ocean Pacific Elements - Nitrile Examination Gloves - Biodegradable - Chemotherapy Tested - Textured Fingertips - Powder Free - Non-Sterile - Blue - Sample pack

AMD Medicom Inc

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

• Primary Device ID: 00686864060741
• NIH Device Record Key: e6d1ab5a-e725-4de4-9d30-9e12f3202446
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ocean Pacific Elements
• Version Model Number: OPBIO-SP6
• Catalog Number: OPBIO-SP6
• Company DUNS: 256880576
• Company Name: AMD Medicom Inc
• Device Count: 6
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00686864060741 [Unit of Use]
GS1	10686864060748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200581

FDA Product Code

• LZC: Patient Examination Glove, Specialty

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: 2024-06-21
• Device Publish Date: 2024-06-13

Devices Manufactured by AMD Medicom Inc

• 20686864061933 - MEDICOM ASSUREMASK VALIANT: 2026-03-25 ASSUREMASK - PROCEDURE EARLOOP FACE MASK - LEVEL 3 - BLUE
• 20686864061940 - MEDICOM ASSUREMASK VALIANT: 2026-03-25 ASSUREMASK - PROCEDURE EARLOOP FACE MASK - LEVEL 3 - BLUE
• 20686864060943 - MEDICOM DENTICARE: 2026-03-05 Medicom DentiCare Spin DPA, Soft Cup - Gray
• 20686864060950 - MEDICOM DENTICARE: 2026-03-05 Medicom DentiCare Spin DPA, Firm Cup - white
• D8304405062 - PROFESSIONAL'S CHOICE: 2026-02-18 PROFESSIONAL'S CHOICE, Self-Seal Sterilization Pouches, 5.25" x 7.5" (13.3cm x 19cm)
• D8305514332 - MEDICOM: 2026-02-18 Sterilization Roll 3" X 100', made with recyclable Tyvek material
• 20686864061643 - MEDICOM: 2025-11-28 MEDICOM SafeMask Signature - Procedure Earloop Facemask - Fog-Free - Blue - Level 3
• 20686864061650 - MEDICOM: 2025-11-28 MEDICOM SafeMask Signature - Procedure Earloop Facemask - Fog-Free - Blue - Level 3