FDA.reportPublic FDA data

Fluoro-Shield

Primary DI
10857164008031
Brand
Fluoro-Shield
Company
MUNDY MEDICAL MARKETING INC
Model
011733M
Catalog number
011733M
Device description
Radiation Reduction Gloves, Size 8 1/2
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
10857164008031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085716400803110857164008031

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.

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
10857164008048Fluoro-Shield011734M011734M2018-06-12
00857164008003Fluoro-Shield011730M011730M2018-06-12
00857164008010Fluoro-Shield011731M0011731M2018-06-12
00857164008027Fluoro-Shield011732M011732M2018-06-12
00857164008034Fluoro-Shield011733M0117333M2018-06-12
00857164008041Fluoro-Shield011734M011734M2018-06-12

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Primary DI, Brand, Company table
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20680651500711HalyardO&M HALYARD, INC.LZC2026-06-04
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
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