PremierPro Surgeons Glove

Basic Information

• Brand Name: PremierPro Surgeons Glove
• Primary DI: 00811220030520
• Version / Model: 43280
• Catalog Number: 43280
• Company Name: SVS LLC
• Labeler DUNS: 831375089
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-14
• Public Version: 2
• Public Version Date: 2020-06-19
• Public Version Status: Update
• Public Device Record Key: cf348cf1-6ac6-4534-95db-b76d3853da4a

Device Description

Pair of Sterile Polyisoprene Gloves Size: Green Size:8.0

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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
59023	Polyisoprene surgical glove, non-powdered, antimicrobial	A device made of polyisoprene intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; it includes an antimicrobial or antiviral agent/properties to reduce viable-microbe exposure in case of sharp penetration and its inner surface is not covered with powder. It is used mainly as a two-way barrier to protect patient and staff from contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, 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	20811220030524	GS1	Case	4	In Commercial Distribution
Package	10811220030527	GS1	Box	50	In Commercial Distribution
Primary	00811220030520	GS1

Customer Contacts

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