AccessGUDID - DEVICE: PurCel Labs Small Vinyl Exam Gloves (00810143550221)

GUDID

Device Identifier (DI) Information

Brand Name: PurCel Labs Small Vinyl Exam Gloves
Version or Model: 1200-150
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Purcel Labs LLC

Primary DI Number: 00810143550221
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 150
Labeler D-U-N-S® Number*: 127672531 *Terms of Use

Device Description: Clear Vinyl Exam Gloves, Size Small, Medical Grade, Ambidextrous, Latex-Free, Powder-Free, Single Use, Non-Sterile, (150/Box).

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?
47176	Vinyl examination/treatment glove, non-powdered	A non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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
LYZ	Vinyl Patient Examination Glove

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102444	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
Storage Environment Temperature: between 5 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 020edab6-c3c2-4285-9dfe-b032897ead48
Public Version Date: October 27, 2023
Public Version Number: 3
DI Record Publish Date: August 04, 2023