P&P Medical Surgical LLC - Disposable Nitrile Gloves Powder & Latex Free - P&P Medical Surgical LLC

Duns Number:022925151

Device Description: Disposable Nitrile Gloves Powder & Latex Free Medical Exam Grade Hypoallergenic Highest Qu Disposable Nitrile Gloves Powder & Latex Free Medical Exam Grade Hypoallergenic Highest Quality Medium Size M Box of 100

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More Product Details

Catalog Number

-

Brand Name

P&P Medical Surgical LLC

Version/Model Number

01700

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Safe

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

-

Product Code Details

Product Code

IWP

Product Code Name

Radiographic Protective Glove

Device Record Status

Public Device Record Key

e43ace1e-2c00-42ee-a3bb-fc8ca4adcb2e

Public Version Date

February 22, 2022

Public Version Number

1

DI Record Publish Date

February 14, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"P&P MEDICAL SURGICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 53
2 A medical device with a moderate to high risk that requires special controls. 4