Spunlace Regular Surgical Gown (Non-Sterile)-M

GUDID 14710415369229

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.

MEDTECS (TAIWAN) CORP.

Surgical gown, single-use
Primary Device ID14710415369229
NIH Device Record Keya7e40fd9-420e-4c01-84e0-671f322ab251
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpunlace Regular Surgical Gown (Non-Sterile)-M
Version Model NumberJCSG80700M
Company DUNS658023890
Company NameMEDTECS (TAIWAN) CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS104710415369222 [Primary]
GS114710415369229 [Package]
Contains: 04710415369222
Package: Carton [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[14710415369229]

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Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-04
Device Publish Date2020-11-26

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