Stronghold SMS Reinforced Surgical Gown (Sterile)-XXL - The Stronghold SMS Reinforced Gown is a device - The Stronghold Group LLC

Duns Number:080344373

Device Description: The Stronghold SMS Reinforced Gown is a device that is intended to be worn by operating ro The Stronghold SMS Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. The gowns are sterilized with EtO sterilization IAW ISO 11135.

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More Product Details

Catalog Number

-

Brand Name

Stronghold SMS Reinforced Surgical Gown (Sterile)-XXL

Version/Model Number

SC301XXL

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

FYA

Product Code Name

Gown, Surgical

Device Record Status

Public Device Record Key

96c4cb00-31cf-4ac9-87d7-43973f233d67

Public Version Date

December 03, 2021

Public Version Number

1

DI Record Publish Date

November 25, 2021

Additional Identifiers

Package DI Number

00850037694150

Quantity per Package

25

Contains DI Package

00850037694112

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