Spunlace Regular Surgical Gown (Non-Sterile)-XXL - The SPUNLACE Regular Gown is a device that is - MEDTECS (TAIWAN) CORP.

Duns Number:658023890

Device Description: The SPUNLACE Regular Gown is a device that is intended to be worn by operating room person The SPUNLACE Regular 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. The SPUNLACE Regular Gown is made from SPUNLACE material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. 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.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Spunlace Regular Surgical Gown (Non-Sterile)-XXL

Version/Model Number

JCSG80700XXL

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

6698b294-ca31-4da5-8199-a207d2ae1de3

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

November 26, 2020

Additional Identifiers

Package DI Number

14710415369250

Quantity per Package

25

Contains DI Package

04710415369253

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