Zhende SG-WR

FDA UDI

Class II (US FDA UDI)

by Xuchang Zhengde Environstar Medical Products Co., Ltd.

Identity

Trade Name: Zhende SG-WR FDA UDI
Generic Name: Surgical gown, single-use FDA UDI
Device Name: Surgical Gown With Reinforcement, L, AAMI PB70 Level 3, 1 piece/bag, 28 pieces/carton FDA UDI
Model / Reference: ZD23102K FDA UDI
Description: Surgical Gown With Reinforcement, L, AAMI PB70 Level 3, 1 piece/bag, 28 pieces/carton FDA UDI

Identifiers

Primary DI / UDI-DI: 06971004783289 FDA UDI
FDA Product Code: FYA FDA UDI
GMDN Term: Surgical gown, single-use FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical gown, single-use

Zhende SG-WR by Xuchang Zhengde Environstar Medical Products Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical gown, single-use.

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Medline — MEDLINE INDUSTRIES, INC. · Class II
Reinforce Surgical Gown (AAMI Level 3) — Foshan Nanhai Plus Medical Co., Ltd · Class II
MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
Beaver Visitec Inter — GRI Medical & Electronic Technology Co., Ltd. · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class II
T7 — Stryker Corp. · Class II

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 II	Pending data

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Manufacturer

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

Sources (1)

FDA UDI cce92e0c-e21d-41ba-997c-c6900e55b807 33 fields · synced May 31, 2026