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Aura

FDA UDI

Class I (US FDA UDI)

by Guangdong KINGFA SCI.&TECH. Co., Ltd.

Identity

Trade Name
AURA FDA UDI
Generic Name
Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Device Name
Aura Exam Premium Nitrile Examination Gloves:KG-1801(GNS-XM\GNM-XM\GNL-XM\GNXL-XM) FDA UDI
Model / Reference
KG-1801(GNM-XM) FDA UDI
Description
Aura Exam Premium Nitrile Examination Gloves:KG-1801(GNS-XM\GNM-XM\GNL-XM\GNXL-XM) FDA UDI

Identifiers

Primary DI / UDI-DI
16976739561918 FDA UDI
510(k) Number
K203593 FDA UDI
FDA Product Code
LZA FDA UDI
GMDN Term
Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Aura by Guangdong KINGFA SCI.&TECH. Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nitrile examination/treatment glove, non-powdered, non-antimicrobial.

Cleared under the same submission

K203593 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Guangdong KINGFA SCI.&TECH. Co., Ltd.

Sources (1)

  • FDA UDI 27d9394c-9db3-4415-81f7-c6804897c28f 34 fields · synced May 31, 2026