FDA.reportPublic FDA data

Zhende SG-WR

Primary DI
06971004783319
Brand
Zhende SG-WR
Company
Xuchang Zhengde Environstar Medical Products Co., Ltd.
Model
ZD23103K
Device description
Surgical Gown With Reinforcement, XL, AAMI PB70 Level 3, 1 piece/bag, 26 pieces/carton
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FYAGown, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971004783319PackageGS126In Commercial Distribution
06971004783302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971004783319069710047833196971004783319
06971004783302069710047833026971004783302

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

Regulatory Flags#

DUNS number
421272799
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06931747835652ZDZD23502N2026-02-01
06931747830480COVETRUS0775222023-06-28
06931747830497COVETRUS0775222023-06-28
06971004783289Zhende SG-WRZD23102K2020-09-01
06971004783302Zhende SG-WRZD23103K2020-09-01
06971004783326Zhende SG-WRZD23104K2020-09-01
06971004783265Zhende SG-WRZD23101K2020-08-31
06971004783296Zhende SG-WRZD23102K2020-09-01
06971004783333Zhende SG-WRZD23104K2020-09-01
06971004784835ZD Isolation Gown-CPZDB120035A2020-08-03
06971004784842ZD Isolation Gown-CPZDB120035A2020-08-03
06971004784811ZD Isolation Gown-CPZDB120034A2020-07-31
06971004784828ZD Isolation Gown-CPZDB120034A2020-07-31
06971004783104ZD Isolation Gown-CZDB1200172020-06-15
06971004783128ZD Isolation Gown-CZDB1200182020-06-15
06971004783111ZD Isolation Gown-CZDB1200172020-06-15
06971004783135ZD Isolation Gown-CZDB1200182020-06-15
06971004782862ZD Isolation Gown-CPZDB120001A2020-04-17
06971004782886ZD Isolation Gown-CPZDB120002A2020-04-17
06971004782879ZD Isolation Gown-CPZDB120001A2020-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918196756AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-10-15
16942748412121AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-10-15
16942748480953AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-10-15
00627755521002Lac-MacLac-Mac LimitedFYA2026-10-13
16931918113425AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918143040AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918143217AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918143248AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918153704AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918155159AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918182988AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918192208AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918195544AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918198286AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
04719882251900CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
04719882251924CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
04719882251948CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
04719882251962CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
09009607835207ViVi® PEEL-OFF TOGA PREMIUM XL-XXLTHI Total Healthcare Innovation GmbHFYA2026-07-22
09009607835214ViVi® PEEL-OFF TOGA PREMIUM M-LTHI Total Healthcare Innovation GmbHFYA2026-07-22
09009607835221ViVi® PEEL-OFF TOGA PREMIUM XXS-STHI Total Healthcare Innovation GmbHFYA2026-07-22
09009607835238ViVi® PEEL-OFF TOGA PREMIUM 3XLTHI Total Healthcare Innovation GmbHFYA2026-07-22
10193489135909MEDLINEMEDLINE INDUSTRIES, INC.FYA2026-07-17
04719882251887CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-06-25
50885380134560CARDINAL HEALTHCardinal Health 200, LLCFYA2026-06-24
16931918123325AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-06-04
08809518442430SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442447SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442454SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442461SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07