FDA.reportPublic FDA data

Protech Proguard

Primary DI
08054301890183
Brand
Protech Proguard
Company
EMERSON & CO SRL
Model
RR390
Catalog number
RR390
Device description
Radiation Reducing Glove
Published
2018-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
08054301890923PackageGS13In Commercial Distribution
08054301890183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054301890923080543018909238054301890923
08054301890183080543018901838054301890183

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding gloveA personal protective device used to shield the entire hand or hands of an individual (i.e., the operator or other attending person) from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical procedures. Each finger is shielded individually. When used in diagnostic x-ray and nuclear medicine, it typically consists of a fluid resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material. The glove offers radiation protection from all directions to the fingers, top and bottom of the hand. Some provide an additional physical barrier protection from liquid radioactive materials and body fluids.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00in a dry place away from light and heat sources (below 35°)

Regulatory Flags#

DUNS number
630558211
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054301890602FreeguardModel160Model1602018-03-16
08054301890619FreeguardModel165Model1652018-03-16
08054301890626FreeguardModel170Model1702018-03-16
08054301890633FreeguardModel175Model1752018-03-16
08054301890640FreeguardModel180Model1802018-03-16
08054301890657FreeguardModel185Model1852018-03-16
08054301890664FreeguardModel190Model1902018-03-16
08054301890671FreeguardModel260Model2602018-03-16
08054301890688FreeguardModel265Model2652018-03-16
08054301890695FreeguardModel270Model2702018-03-16
08054301890701FreeguardModel275Model2752018-03-16
08054301890718FreeguardModel280Model2802018-03-16
08054301890725FreeguardModel285Model2852018-03-16
08054301890732FreeguardModel290Model2902018-03-16
08054301891500FreeguardModel170Model1702021-01-26
08054301891517FreeguardModel175Model1752021-01-26
08054301891531FreeguardModel185Model1852021-01-28
08054301891548FreeguardModel190Model1902021-01-28
08054301891555FreeguardModel260Model2602021-01-28
08054301891562FreeguardModel265Model2652021-01-28

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
G031101MITRL0Lead MittensShielding 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