JMU - JMU Disposable Nitrile Exam Gloves, Powder-free, - JMU DENTAL, INC

Duns Number:081258380

Device Description: JMU Disposable Nitrile Exam Gloves, Powder-free, Non-Sterile, Ambidextrous, Size S, Blue, JMU Disposable Nitrile Exam Gloves, Powder-free, Non-Sterile, Ambidextrous, Size S, Blue, 100pcs/Box

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More Product Details

Catalog Number

-

Brand Name

JMU

Version/Model Number

25301005

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"

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

K110981

Product Code Details

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

5e2a908e-1025-486d-9896-91217c1c856c

Public Version Date

November 04, 2021

Public Version Number

1

DI Record Publish Date

October 27, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JMU DENTAL, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10