sunnycare - SUNNYCARE brand nitrile examination gloves powder - Agio Group Inc.

Duns Number:611739033

Device Description: SUNNYCARE brand nitrile examination gloves powder free blue medium size 100pcs/box, 10 bo SUNNYCARE brand nitrile examination gloves powder free blue medium size 100pcs/box, 10 boxes/case 5 mil

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More Product Details

Catalog Number

8602

Brand Name

sunnycare

Version/Model Number

8602

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

386118c2-c21e-41ad-a6b7-a833e5365a88

Public Version Date

October 06, 2022

Public Version Number

1

DI Record Publish Date

September 28, 2022

Additional Identifiers

Package DI Number

20850044355734

Quantity per Package

10

Contains DI Package

10850044355737

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

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