Catalog Number

-

Brand Name

Safe-Touch Black Nitrile Examination Gloves, Powder-Free

Version/Model Number

2521

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

K133307,K133307,K133307

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

ef2414f0-9e42-46d1-9d3a-a0f82e362883

Public Version Date

September 14, 2022

Public Version Number

1

DI Record Publish Date

September 06, 2022

Package DI Number

00616784252131

Quantity per Package

10

Contains DI Package

00616784252124

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case