Criterion N250 Nitrile PF Glove - Criterion N250 PF Nitrile Glove X-LARGE - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: Criterion N250 PF Nitrile Glove X-LARGE

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More Product Details

Catalog Number

5700103

Brand Name

Criterion N250 Nitrile PF Glove

Version/Model Number

5700103

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

e2c89187-25a7-40c8-b0c1-7075d76f6ca8

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

January 03, 2020

Additional Identifiers

Package DI Number

10304040077600

Quantity per Package

10

Contains DI Package

00304040077603

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"HENRY SCHEIN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3829
2 A medical device with a moderate to high risk that requires special controls. 2579
3 A medical device with high risk that requires premarket approval 1
U Unclassified 34