AccessGUDID - DEVICE: SHOWA (00038054256180)

GUDID

Device Identifier (DI) Information

Brand Name: SHOWA
Version or Model: M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5005PFM
Company Name: SHOWA BEST GLOVE, INC.

Primary DI Number: 00038054256180
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 807930412 *Terms of Use

Device Description: Latex PF Exam , polymer coated, low protein, natural rubber latex, 9.5"/240mm, rolled cuff, bisque grip, M

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?
60951	Hevea-latex surgical glove, non-powdered, antimicrobial	A device containing Hevea natural rubber latex (NRL) [e.g., NRL/polymer composite] intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; it includes an antimicrobial or antiviral agent/properties intended to reduce viable-microbe exposure in case of sharp penetration and its inner surface is not covered with powder. It is used mainly as a two-way barrier to protect both the patient and the staff against 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYY	Latex Patient Examination Glove

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No Device Sizes

Device Record Status

Public Device Record Key: 48310295-b6dd-4286-af85-502136bd62f3
Public Version Date: April 03, 2023
Public Version Number: 1
DI Record Publish Date: March 24, 2023