FDA.reportPublic FDA data

ZD Isolation Gown-CP

Primary DI
06971004784811
Brand
ZD Isolation Gown-CP
Company
Xuchang Zhengde Environstar Medical Products Co., Ltd.
Model
ZDB120034A
Device description
Isolation Gown, L, 10 pieces/bag. 10 bags/case
Published
2020-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971004784828PackageGS110In Commercial Distribution
06971004784811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971004784828069710047848286971004784828
06971004784811069710047848116971004784811

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Regulatory Flags#

DUNS number
421272799
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
06971004783319Zhende SG-WRZD23103K2020-09-01
06971004783333Zhende SG-WRZD23104K2020-09-01
06971004784835ZD Isolation Gown-CPZDB120035A2020-08-03
06971004784842ZD Isolation Gown-CPZDB120035A2020-08-03
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199536901421BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901438BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901445BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901452BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901469BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901476BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
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