Strong Manufacturers - Nitrile Chemo Tested Exam Gloves, Powder Free, - Strong Medical Partners LLC

Duns Number:062388929

Device Description: Nitrile Chemo Tested Exam Gloves, Powder Free, Size Large (L), Blue

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More Product Details

Catalog Number

1004

Brand Name

Strong Manufacturers

Version/Model Number

1004

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)

Yes

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

a944ae40-09ee-4ffa-8b1c-a9a9af2dc624

Public Version Date

September 20, 2021

Public Version Number

1

DI Record Publish Date

September 10, 2021

Additional Identifiers

Package DI Number

10853927007037

Quantity per Package

2000

Contains DI Package

00853927007030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"STRONG MEDICAL PARTNERS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 79
2 A medical device with a moderate to high risk that requires special controls. 5