Medline Industries, Inc. - LARGE GLOVES - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: LARGE GLOVES

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More Product Details

Catalog Number

DYNDA2070

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNDA2070

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)

Yes

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

731ce2f0-c3ba-4fce-b3d9-12f9bd013b10

Public Version Date

August 12, 2022

Public Version Number

1

DI Record Publish Date

August 04, 2022

Additional Identifiers

Package DI Number

40889942717744

Quantity per Package

10

Contains DI Package

10889942717743

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"MEDLINE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38540
2 A medical device with a moderate to high risk that requires special controls. 85094
3 A medical device with high risk that requires premarket approval 2
U Unclassified 7