Ocean Pacific NeoNatural

Basic Information

• Brand Name: Ocean Pacific NeoNatural
• Primary DI: 20686864059565
• Version / Model: 1228-SP6
• Catalog Number: 1228-SP6
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2022-06-28
• Public Version: 3
• Public Version Date: 2023-05-25
• Public Version Status: Update
• Public Device Record Key: 566be19b-fbb0-4088-beda-1d7a02f2e8d4

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LZA	Polymer patient examination glove	General Hospital	880.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56288	Polychloroprene examination/treatment glove, non-powdered	A device made of polychloroprene (neoprene) intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00686864059561	GS1
Primary	20686864059565	GS1

Customer Contacts

• Phone: [phone] ext. 2309
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K040607	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Cool dry place - Avoid excessive heat (40°C/104°F)