AccessGUDID - DEVICE: Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove (B086101241)

GUDID

Device Identifier (DI) Information

Brand Name: Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove
Version or Model: P10124
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P10124
Company Name: PROTECT U GUARD, LLC

Primary DI Number: B086101241
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 250
Labeler D-U-N-S® Number*: 080070945 *Terms of Use

Device Description: Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove , Single Use, Non-Sterile, Powder Free, Low Dermatitis Potential Box of 250 Gloves

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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
56286	Nitrile examination/treatment glove, non-powdered, non-antimicrobial	A device made of nitrile 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 patient/staff against 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, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZC	Patient Examination Glove, Specialty
LZA	Polymer Patient Examination Glove

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151824	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: Extra Large

Device Record Status

Public Device Record Key: 9aef069b-3bb8-4b58-918b-0d36559903d5
Public Version Date: June 19, 2020
Public Version Number: 2
DI Record Publish Date: August 27, 2018