Catalog Number

-

Brand Name

ToughGrip 7 Mil Latex Gloves - XL

Version/Model Number

S-19177X

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)

Yes

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

K152593,K152593,K152593

Product Code

LYY

Product Code Name

Latex Patient Examination Glove

Public Device Record Key

c1fe57e0-1cd5-4425-afde-400935439879

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

December 16, 2019

Package DI Number

30851253007817

Quantity per Package

10

Contains DI Package

10851253007813

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-