Cerulean - Powder Free Nitrile Exam Gloves (Blue) Large - J & A Global Inc.

Duns Number:603660460

Device Description: Powder Free Nitrile Exam Gloves (Blue) Large

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More Product Details

Catalog Number

-

Brand Name

Cerulean

Version/Model Number

NC-352003L

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

eab72cbe-98f5-4852-8176-b580b386d445

Public Version Date

July 20, 2022

Public Version Number

1

DI Record Publish Date

July 12, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"J & A GLOBAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1