AccessGUDID - DEVICE: Spunlace Reinforced Surgical Gown (Non-Sterile)-L (04710415369314)

GUDID

Device Identifier (DI) Information

Brand Name: Spunlace Reinforced Surgical Gown (Non-Sterile)-L
Version or Model: JCSG84700L
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTECS (TAIWAN) CORP.

Primary DI Number: 04710415369314
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658023890 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35091	Surgical gown, single-use	A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FYA	Gown, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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