Catalog Number

8645XL

Brand Name

Diversamed

Version/Model Number

8645XL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K110981

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

53ec2765-4815-44d3-8a9a-673c08223495

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

April 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-