Disposable Isolation Gown

FDA UDI

Class I (US FDA UDI)

by Tng Investment And Trading Joint Stock Company

Identity

Trade Name: Disposable Isolation Gown FDA UDI
Generic Name: Isolation gown, single-use FDA UDI
Device Name: Non-woven fabric Gown with elastic band inside cuff, non-zipper, back tie, disposable FDA UDI
Model / Reference: Y0146 FDA UDI
Description: Non-woven fabric Gown with elastic band inside cuff, non-zipper, back tie, disposable FDA UDI

Identifiers

Primary DI / UDI-DI: 08936064200020 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

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

Yes

FDA UDI

Category: Isolation gown, single-use

Disposable Isolation Gown by Tng Investment And Trading Joint Stock Company — 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: Tng Investment And Trading Joint Stock Company

Sources (1)

FDA UDI d608a0bb-8f4c-48e6-b129-ad055a888ef2 33 fields · synced Jun 8, 2026