Duns Number:658023890
Device Description: The Spunlace Reinforced Gown is a device that is intended to be worn by operating room per The Spunlace 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. The Spunlace Reinforced Gown is made from Spunlace 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.
Catalog Number
-
Brand Name
Spunlace Reinforced Surgical Gown (Non-Sterile)-L
Version/Model Number
JCSG84700L
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
FYA
Product Code Name
Gown, Surgical
Public Device Record Key
97bda3ca-60e7-45d2-a092-82eeba40a76d
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
November 26, 2020
Package DI Number
14710415369311
Quantity per Package
25
Contains DI Package
04710415369314
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |