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Fluoro-Shield

FDA UDI

Class I (US FDA UDI)

by Mundy Medical Marketing, Inc.

Identity

Trade Name
Fluoro-Shield FDA UDI
Generic Name
Radiation shielding glove FDA UDI
Device Name
Radiation Reduction Gloves, Size 9 FDA UDI
Model / Reference
011734M FDA UDI
Description
Radiation Reduction Gloves, Size 9 FDA UDI

Identifiers

Catalog Number
011734M FDA UDI
Primary DI / UDI-DI
00857164008041 FDA UDI
510(k) Number
K893093 FDA UDI
FDA Product Code
LZC FDA UDI
GMDN Term
Radiation shielding glove 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

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

No

FDA UDI

Category: Radiation shielding glove

Fluoro-Shield by Mundy Medical Marketing, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiation shielding glove.

Cleared under the same submission

K893093 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mundy Medical Marketing, Inc.

Sources (1)

  • FDA UDI ba0aed5c-279e-4ba7-8aa4-d01fbfa2f016 35 fields · synced Jun 1, 2026