Green Guard Sani Safe Glove Dispenser - Polymer patient exam gloves - Greenguard

Duns Number:176528040

Device Description: Polymer patient exam gloves

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More Product Details

Catalog Number

7915

Brand Name

Green Guard Sani Safe Glove Dispenser

Version/Model Number

7915

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

ed51e50f-1fb1-479b-80cd-1b1f28ace535

Public Version Date

July 04, 2019

Public Version Number

1

DI Record Publish Date

June 26, 2019

Additional Identifiers

Package DI Number

50347682791556

Quantity per Package

24

Contains DI Package

00347682791551

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

master case

"GREENGUARD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 1
U Unclassified 1