Spunlace Regular Surgical Gown (Non-Sterile)-XL

Primary DI
14710415369243
Brand
Spunlace Regular Surgical Gown (Non-Sterile)-XL
Company
MEDTECS (TAIWAN) CORP.
Model
JCSG80700XL
Device description
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.
Published
2020-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FYAGown, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102692000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102692000SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFOHangzhou Jincheng Medical Supplier Manufacture Co.2011-03-11FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14710415369243PackageGS125In Commercial Distribution
04710415369246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471041536924314710415369243
04710415369246047104153692464710415369246

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA garment made of natural and/or synthetic materials intended to be worn 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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
658023890
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00850047202178NITRILE EXAM GLOVES-Blue-200pcs-MBlue-200pcs-M2023-06-17
00850047202185NITRILE EXAM GLOVES-Blue-200pcs-SBlue-200pcs-S2023-06-17
00850047202192NITRILE EXAM GLOVES-Blue-200pcs-XSBlue-200pcs-XS2023-06-17
00850047202208NITRILE EXAM GLOVES-Cool Blue-200pcs-XLCool Blue-200pcs-XL2023-06-17
00850047202215NITRILE EXAM GLOVES-Cool Blue-200pcs-LCool Blue-200pcs-L2023-06-17
00850047202239NITRILE EXAM GLOVES-Cool Blue-200pcs-SCool Blue-200pcs-S2023-06-17
00850047202277NITRILE EXAM GLOVES-Black-200pcs-MBlack-200pcs-M2023-06-17
00850047202284NITRILE EXAM GLOVES-Black-200pcs-SBlack-200pcs-S2023-06-17
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00850047202512NITRILE EXAM GLOVES-Black-100pcs-LBlack-100pcs-L2023-11-08
00850047202529NITRILE EXAM GLOVES-Black-100pcs-MBlack-100pcs-M2023-11-08
00850047202536NITRILE EXAM GLOVES-Black-100pcs-SBlack-100pcs-S2023-11-08
00850047202543NITRILE EXAM GLOVES-Black-100pcs-XSBlack-100pcs-XS2023-11-08
00850047202222NITRILE EXAM GLOVES-Cool Blue-200pcs-MCool Blue-200pcs-M2023-06-17
00850047202246NITRILE EXAM GLOVES-Cool Blue-200pcs-XSCool Blue-200pcs-XS2023-06-17
00850047202253NITRILE EXAM GLOVES-Black-200pcs-XLBlack-200pcs-XL2023-06-17
00850047202260NITRILE EXAM GLOVES-Black-200pcs-LBlack-200pcs-L2023-06-17

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