Stronghold PP/PE Isolation Gown (AAMI Level 2)-M - This gown is intended to protect health care - The Stronghold Group LLC

Duns Number:080344373

Device Description: This gown is intended to protect health care patients and health care personnel from the t This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Pack of 10.

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More Product Details

Catalog Number

-

Brand Name

Stronghold PP/PE Isolation Gown (AAMI Level 2)-M

Version/Model Number

SC200M

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

OEA

Product Code Name

Non-Surgical Isolation Gown

Device Record Status

Public Device Record Key

86f73d6f-267e-4302-bfc6-8a6b44b01fc6

Public Version Date

March 28, 2022

Public Version Number

1

DI Record Publish Date

March 19, 2022

Additional Identifiers

Package DI Number

00850037694693

Quantity per Package

10

Contains DI Package

00850037694655

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"THE STRONGHOLD GROUP LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 8