Catalog Number

-

Brand Name

Sentinel Guardian - Nitrile

Version/Model Number

G-GNF12-Sm

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"

Yes

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

K161929,K161929,K161929

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

47fa4b78-fa66-485c-8d3a-1df5acbe1987

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 23, 2022

Package DI Number

10850036973000

Quantity per Package

10

Contains DI Package

00850036973003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case