Halyard - Blue Nitrile Powder-Free Exam Gloves, X-Large - O&M HALYARD, INC.

Duns Number:081057389

Device Description: Blue Nitrile Powder-Free Exam Gloves, X-Large

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More Product Details

Catalog Number

53104

Brand Name

Halyard

Version/Model Number

53104

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

K962139,K962139,K962139

Product Code Details

Product Code

LZA

Product Code Name

Polymer patient examination glove

Device Record Status

Public Device Record Key

9991ee55-d121-46e6-81c9-0da9c6a8b53c

Public Version Date

September 23, 2020

Public Version Number

1

DI Record Publish Date

September 15, 2020

Additional Identifiers

Package DI Number

30680651531040

Quantity per Package

10

Contains DI Package

20680651531043

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"O&M HALYARD, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 1044