FDA.reportPublic FDA data

Fluoro-Shield

Primary DI
00857164008003
Brand
Fluoro-Shield
Company
MUNDY MEDICAL MARKETING INC
Model
011730M
Catalog number
011730M
Device description
Radiation Reduction Gloves, Size 7
Published
2018-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K893093000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K893093000FLOUROSHIELD RADIATION REDUCTION GLOVEAcufex Microsurgical, Inc.1990-02-13LZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857164008003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857164008003008571640080038571640080030857164008003

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
097037857
Device count
1
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
00857164008058TM100 PADTM100 PADTM100 PAD2018-06-12
10857164008000Fluoro-Shield011730M011730M2018-06-12
10857164008017Fluoro-Shield011731M011731M2018-06-12
10857164008024Fluoro-Shield011732M011732M2018-06-12
10857164008031Fluoro-Shield011733M011733M2018-06-12
10857164008048Fluoro-Shield011734M011734M2018-06-12
00857164008010Fluoro-Shield011731M0011731M2018-06-12
00857164008027Fluoro-Shield011732M011732M2018-06-12
00857164008034Fluoro-Shield011733M0117333M2018-06-12
00857164008041Fluoro-Shield011734M011734M2018-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10850015055932EXT CUFF 12 MIL LATEX GLOVES-SULINE, INC.LZC2026-07-10
10850015055949EXT CUFF 12 MIL LATEX GLOVES-XULINE, INC.LZC2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
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20680651500704HalyardO&M HALYARD, INC.LZC2026-06-04
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20680651502388HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZC2026-06-04