Catalog Number

-

Brand Name

Gloves

Version/Model Number

12290

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

K093270,K093270,K093270

Product Code

LYZ

Product Code Name

Vinyl Patient Examination Glove

Public Device Record Key

efe08d5f-3923-4f7d-a1ca-3de197d20262

Public Version Date

September 09, 2019

Public Version Number

1

DI Record Publish Date

September 01, 2019

Package DI Number

00369771001372

Quantity per Package

10

Contains DI Package

00369771001365

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case