Le soothe Latex PF L/R FIT Exam Natural 8.5

Basic Information

• Brand Name: Le soothe Latex PF L/R FIT Exam Natural 8.5
• Primary DI: D76643785N1
• Version / Model: 43785N
• Catalog Number: 43785N
• Company Name: Smarthealth, Inc.
• Labeler DUNS: 061081477
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2023-07-17
• Public Version: 1
• Public Version Date: 2023-07-25
• Public Version Status: New
• Public Device Record Key: 53d23bcc-1f71-458b-bdb4-9fc3e8c8956d

Device Description

GLV LE SOOTHE NP LATEX PF L/R FIT NATURAL STD BX 8.5*50 PR

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
LYY	Latex Patient Examination Glove	General Hospital	880.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47172	Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial	A device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. 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
Package	D76643785N2	HIBCC	case	10	In Commercial Distribution
Primary	D76643785N1	HIBCC
Unit of Use	D76643785N0	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			8.5

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 104 Degrees Fahrenheit