Uline Wht 3 Mil Nitrile Glvs-L - ULINE, INC.

Duns Number:039612668

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More Product Details

Catalog Number

-

Brand Name

Uline Wht 3 Mil Nitrile Glvs-L

Version/Model Number

S-21082-L

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

K170393,K170393,K170393

Product Code Details

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

44c283f4-57d1-45e7-9b9b-81e135dc9218

Public Version Date

August 05, 2021

Public Version Number

1

DI Record Publish Date

July 28, 2021

Additional Identifiers

Package DI Number

30850015055189

Quantity per Package

10

Contains DI Package

10850015055222

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ULINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 1
U Unclassified 2