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Superfit

FDA UDI

Class I (US FDA UDI)

by Applied Dental, Inc.

Identity

Trade Name
SUPERFIT FDA UDI
Generic Name
Nitrile surgical glove, non-powdered FDA UDI
Device Name
SUPERFIT Disposable Nitrile Surgical Gloves. Powder Free. Size 8.0. Sterile. FDA UDI
Model / Reference
A560-N80 FDA UDI
Description
SUPERFIT Disposable Nitrile Surgical Gloves. Powder Free. Size 8.0. Sterile. FDA UDI

Identifiers

Primary DI / UDI-DI
00814639023244 FDA UDI
510(k) Number
K122557 FDA UDI
FDA Product Code
KGO FDA UDI
GMDN Term
Nitrile surgical glove, non-powdered FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4460 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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 surgical glove, non-powdered

Superfit by Applied Dental, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nitrile surgical glove, non-powdered.

Cleared under the same submission

K122557 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Applied Dental, Inc.

Sources (1)

  • FDA UDI 8230551d-06af-41af-a027-5f4dfa3b5496 35 fields · synced May 30, 2026