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Superfit

FDA UDI

Class I (US FDA UDI)

by Applied Dental, Inc.

Identity

Trade Name
SUPERFIT FDA UDI
Generic Name
Hevea-latex surgical glove, non-powdered, antimicrobial FDA UDI
Device Name
SUPERFIT Disposable Latex Surgical Gloves. Powder Free. Size 6.5. FDA UDI
Model / Reference
A520-LTX65 FDA UDI
Description
SUPERFIT Disposable Latex Surgical Gloves. Powder Free. Size 6.5. FDA UDI

Identifiers

Primary DI / UDI-DI
00814639023381 FDA UDI
510(k) Number
K063757 FDA UDI
FDA Product Code
KGO FDA UDI
GMDN Term
Hevea-latex surgical glove, non-powdered, antimicrobial 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hevea-latex surgical glove, non-powdered, antimicrobial

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

Similar devices

Also classified as Hevea-latex surgical glove, non-powdered, antimicrobial.

Cleared under the same submission

K063757 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 5a270588-7425-45d1-85a4-ced3ffa69814 35 fields · synced May 30, 2026