ZD Isolation Gown-C

FDA UDI

Class I (US FDA UDI)

by Xuchang Zhengde Environstar Medical Products Co., Ltd.

Identity

Trade Name: ZD Isolation Gown-C FDA UDI
Generic Name: Isolation gown, single-use FDA UDI
Device Name: Isolation Gown, L, 10 pieces/bag, 10 bags/case FDA UDI
Model / Reference: ZDB120017 FDA UDI
Description: Isolation Gown, L, 10 pieces/bag, 10 bags/case FDA UDI

Identifiers

Primary DI / UDI-DI: 06971004783104 FDA UDI
FDA Product Code: OEA FDA UDI
GMDN Term: Isolation gown, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Isolation gown, single-use

ZD Isolation Gown-C by Xuchang Zhengde Environstar Medical Products Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Xuchang Zhengde Environstar Medical Products Co., Ltd.

Sources (1)

FDA UDI 4ce18969-7a0a-4157-89a5-a6c1362353fc 33 fields · synced May 30, 2026