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Ideal

FDA UDI

Class I (US FDA UDI)

by Elara Foodservice Disposables LLC

Identity

Trade Name
Ideal FDA UDI
Generic Name
Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Device Name
Black Nitrile Exam 3.5g Glove XL FDA UDI
Model / Reference
902999 FDA UDI
Description
Black Nitrile Exam 3.5g Glove XL FDA UDI

Identifiers

Catalog Number
ID-NTBLK-XL FDA UDI
Primary DI / UDI-DI
00847212008321 FDA UDI
510(k) Number
K133307 FDA UDI
FDA Product Code
LYY 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Ideal by Elara Foodservice Disposables LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K133307 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elara Foodservice Disposables LLC

Sources (1)

  • FDA UDI 9f9ee760-bddc-4c93-84ed-48f3cb6feac3 36 fields · synced Jun 6, 2026