Cirrus - Non Sterile, Powder Free Examination Gloves, XL, - HOURGLASS INTERNATIONAL INC

Duns Number:026777252

Device Description: Non Sterile, Powder Free Examination Gloves, XL, Blue Colored, Tested for Use with Chemoth Non Sterile, Powder Free Examination Gloves, XL, Blue Colored, Tested for Use with Chemotherapy Drugs.

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More Product Details

Catalog Number

-

Brand Name

Cirrus

Version/Model Number

804B

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"

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

-

Product Code Details

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

ca58c9af-6086-4297-bed7-ee49c616fbbf

Public Version Date

December 09, 2021

Public Version Number

1

DI Record Publish Date

December 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HOURGLASS INTERNATIONAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 86