SMS Reinforced Surgical Gown (Non-Sterile)-XXL - The SMS Reinforced Gown is a device that is - MEDTECS (TAIWAN) CORP.

Duns Number:658023890

Device Description: The SMS Reinforced Gown is a device that is intended to be worn by operating room personne The 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. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

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More Product Details

Catalog Number

-

Brand Name

SMS Reinforced Surgical Gown (Non-Sterile)-XXL

Version/Model Number

JCSG74700XXL

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

FYA

Product Code Name

Gown, Surgical

Device Record Status

Public Device Record Key

f7b0749d-0d24-47b8-86f1-a7eb429a689d

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

November 26, 2020

Additional Identifiers

Package DI Number

14710415369175

Quantity per Package

25

Contains DI Package

04710415369178

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"MEDTECS (TAIWAN) CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 28