Medicom AssureTouch

Basic Information

• Brand Name: Medicom AssureTouch
• Primary DI: 10686864060052
• Version / Model: 1147-7.5
• Catalog Number: 1147-7.5
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2024-03-05
• Public Version: 1
• Public Version Date: 2024-03-13
• Public Version Status: New
• Public Device Record Key: aedc2696-d34b-4120-befd-a0e5ce406252

Device Description

Medicom AssureTouch React - Polyisoprene Surgical Gloves - Powder Free - Sterile - Natural White - Size 7.5

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGO	Surgeon'S Gloves	General, Plastic Surgery	878.4460	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56293	Polyisoprene surgical glove, non-powdered, non-antimicrobial	A device made of polyisoprene intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30686864060056	GS1	Inner Box	50	In Commercial Distribution
Primary	10686864060052	GS1
Package	20686864060059	GS1	Outer Case	4	In Commercial Distribution
Unit of Use	00686864060055	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K112654	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			7.5

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool dry place. Avoid excessive heat (40°C, 104°F)