Nulife

Basic Information

• Brand Name: Nulife
• Primary DI: 08905159002146
• Version / Model: Elbow length Gynaecology gloves - 8.5
• Catalog Number: ELGLUE
• Company Name: MRK HEALTHCARE PRIVATE LIMITED
• Labeler DUNS: 650986016
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-28
• Public Version: 1
• Public Version Date: 2023-07-06
• Public Version Status: New
• Public Device Record Key: 6682b72c-a41b-4c06-84b1-dc6116e0531d

Device Description

Elbow Length gynaecology gloves are sterile and anatomically shaped medical gloves with the thumb positioned towards the palmer surface of the index finger rather than lying flat with length till elbow. These gloves are powder-free. The Elbow length gynaecology gloves are intended for use various gynecological procedures.

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
47178	Hevea-latex surgical 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 at the surgical site; 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 contamination from microorganisms. 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
Primary	08905159002146	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K210969	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			8.5