Diversamed - Extra Large Nitrile Powder Free Exam Glove - IMPACT PRODUCTS, LLC

Duns Number:005052360

Device Description: Extra Large Nitrile Powder Free Exam Glove

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More Product Details

Catalog Number

8628XL

Brand Name

Diversamed

Version/Model Number

8628XL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

-

Product Code Details

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

0cee22a9-b23a-4f2d-98f4-7613dc17eff5

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

March 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMPACT PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 48