AccessGUDID - DEVICE: Nulife (08905159002139)

GUDID

Device Identifier (DI) Information

Brand Name: Nulife
Version or Model: Elbow length Gynaecology gloves - 7.5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ELGLUE
Company Name: MRK HEALTHCARE PRIVATE LIMITED

Primary DI Number: 08905159002139
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 650986016 *Terms of Use

Device Description: Elbow Length gynaecology gloves are sterile, 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGO	Surgeon'S Gloves

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210969	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 7.5

Device Record Status

Public Device Record Key: ff2c0ec9-5516-4118-b986-3a808d52d967
Public Version Date: July 06, 2023
Public Version Number: 1
DI Record Publish Date: June 28, 2023