FDA.reportPublic FDA data

Lead Mittens

Primary DI
G031101MITRL0
Brand
Lead Mittens
Company
Shielding International Inc.
Model
101MITRL
Device description
"Lead mittens - 15"" one piece dip molded"
Published
2023-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IWPRadiographic Protective Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWPRadiographic Protective GloveRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G031101MITRL0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiation-shielding procedure preparation glove/mittenA personal protective device intended to be used to shield the entire hand or hands of medical personnel from unnecessary exposure to primary and scattered radiation associated with the preparation of a diagnostic and/or therapeutic radiological procedure (e.g., patient positioning). It is typically intended for procedure set-up or patient positioning; it is not a patient examination/treatment glove, nor a surgical glove. It typically includes a thin layer of lead (Pb) or lead-equivalent material and may be fluid resistant.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009647322
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G031QRSOMFRL0Quick Release Skirt OnlyQRSOMFRL2026-04-28
G031QRSOMMNL0Quick Release Skirt OnlyQRSOMMNL2026-04-28
G031QRSOMMRL0Quick Release Skirt OnlyQRSOMMRL2026-04-28
G031QRSOMMRLL0Quick Release Skirt OnlyQRSOMMRLL2026-04-28
G031QRSOMMTL0Quick Release Skirt OnlyQRSOMMTL2026-04-28
G031QRSOSFNL0Quick Release Skirt OnlyQRSOSFNL2026-04-28
G031QRSOSFRL0Quick Release Skirt OnlyQRSOSFRL2026-04-28
G031QRSOSFRLL0Quick Release Skirt OnlyQRSOSFRLL2026-04-28
G031QRSOSFTL0Quick Release Skirt OnlyQRSOSFTL2026-04-28
G031QRSOSMNL0Quick Release Skirt OnlyQRSOSMNL2026-04-28
G031QRSOSMTL0Quick Release Skirt OnlyQRSOSMTL2026-04-28
G031QRSOSMRLL0Quick Release Skirt OnlyQRSOSMRLL2026-04-22
G031SO2XFRL0SkirtSO2XFRL2026-04-22
G031SO2XFRLL0SkirtSO2XFRLL2026-04-22
G031SO2XFTL0SkirtSO2XFTL2026-04-22
G031SO2XMNL0SkirtSO2XMNL2026-04-22
G031SO2XMRL0SkirtSO2XMRL2026-04-22
G031SO2XMRLL0SkirtSO2XMRLL2026-04-22
G031SO2XMTL0SkirtSO2XMTL2026-04-22
G031SOLFNL0SkirtSOLFNL2026-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010574508APFG65F&L Medical Products LLCIWP2023-11-28
00860010574522APFG75F&L Medical Products LLCIWP2023-11-28
00860010574553APFGXLF&L Medical Products LLCIWP2023-11-28
00860010574515APFG70F&L Medical Products LLCIWP2023-11-27
00860010574539APFG80F&L Medical Products LLCIWP2023-11-27
00860010574546APFG85F&L Medical Products LLCIWP2023-11-27
G031100VRL0Vinyl Lead GlovesShielding International Inc.IWP2023-08-08
G031101SLMITRL0Lead Slit MittensShielding International Inc.IWP2023-08-08
G031104OPMRL0Open Palm MittShielding International Inc.IWP2023-08-08
G031104VMRL0Vet MittShielding International Inc.IWP2023-08-08
G031200LRL0200L - Leather Lead GlovesShielding International Inc.IWP2023-08-08
08904333246673UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246680UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246697UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246703UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246710UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246727UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246734UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246741UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246758UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246765UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246772UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246789UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246796UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246802UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246819UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246826UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246833UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246840UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246857UniRayUNIRAY MEDICAL LLPIWP2023-02-11