Medichoice - Glove Exam XLarge NITRILE Blue For Use With Some - OWENS & MINOR DISTRIBUTION, INC.

Duns Number:007941230

Device Description: Glove Exam XLarge NITRILE Blue For Use With Some Chemotherapy Drugs Not Made With Natural Glove Exam XLarge NITRILE Blue For Use With Some Chemotherapy Drugs Not Made With Natural Rubber Latex

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More Product Details

Catalog Number

-

Brand Name

Medichoice

Version/Model Number

GLV9304

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

K170136,K170136,K170136

Product Code Details

Product Code

LZA

Product Code Name

Polymer patient examination glove

Device Record Status

Public Device Record Key

4178555d-e868-402a-be89-3ddf2f4a8f66

Public Version Date

December 24, 2020

Public Version Number

1

DI Record Publish Date

December 16, 2020

Additional Identifiers

Package DI Number

20885632295321

Quantity per Package

10

Contains DI Package

30885632295328

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"OWENS & MINOR DISTRIBUTION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 428
2 A medical device with a moderate to high risk that requires special controls. 8754
U Unclassified 1