Catalog Number

JVB200SMB

Brand Name

J2 Medical Supply

Version/Model Number

JVB200SMB

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K170136,K170136,K170136

Product Code

LZC

Product Code Name

Patient Examination Glove, Specialty

Public Device Record Key

aef1164b-e9cd-4d55-8340-28eef7ebc3df

Public Version Date

November 01, 2022

Public Version Number

2

DI Record Publish Date

June 04, 2021

Package DI Number

00850020592968

Quantity per Package

10

Contains DI Package

00850020592555

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case