PremierPro - PremierPro Powder Free Vinyl Exam Glove Standard - SVS LLC

Duns Number:831375089

Device Description: PremierPro Powder Free Vinyl Exam Glove Standard X-Large 100 count

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More Product Details

Catalog Number

4045

Brand Name

PremierPro

Version/Model Number

4045

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

K100326,K100326

Product Code Details

Product Code

LYZ

Product Code Name

Vinyl Patient Examination Glove

Device Record Status

Public Device Record Key

1cd2af3d-6fc1-42d5-9609-ea767e12e424

Public Version Date

July 02, 2020

Public Version Number

1

DI Record Publish Date

June 24, 2020

Additional Identifiers

Package DI Number

10854344002537

Quantity per Package

10

Contains DI Package

00854344002530

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"SVS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 486
2 A medical device with a moderate to high risk that requires special controls. 177
U Unclassified 1