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Lead Slit Mittens

FDA UDI

Class I (US FDA UDI)

by Shielding International Inc.

Identity

Trade Name
Lead Slit Mittens FDA UDI
Generic Name
Radiation-shielding procedure preparation glove/mitten FDA UDI
Device Name
Lead mittens - 15" one piece dip molded - w/ slit at base of fingers for dexterity FDA UDI
Model / Reference
101SLMITRL FDA UDI
Description
Lead mittens - 15" one piece dip molded - w/ slit at base of fingers for dexterity FDA UDI

Identifiers

Primary DI / UDI-DI
G031101SLMITRL0 FDA UDI
FDA Product Code
IWP FDA UDI
GMDN Term
Radiation-shielding procedure preparation glove/mitten FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.6500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiation-shielding procedure preparation glove/mitten

Lead Slit Mittens by Shielding International Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiation-shielding procedure preparation glove/mitten.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shielding International Inc.

Sources (1)

  • FDA UDI 349f4dba-b42a-4f36-9fab-581f6f41bcef 33 fields · synced May 30, 2026