Catalog Number

52102-54

Brand Name

KIMTECH PURPLE NITRILE EXAM GLOVES, STERILE SINGLES (M)

Version/Model Number

52102

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

K102032,K102032,K102032

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

78b75f80-f284-4d12-b7cc-afb7e1f17718

Public Version Date

March 23, 2020

Public Version Number

1

DI Record Publish Date

March 13, 2020

Package DI Number

20036000521027

Quantity per Package

4

Contains DI Package

10036000521020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case