FDA.reportPublic FDA data

Bosma Enterprises

Primary DI
40818634020107
Brand
Bosma Enterprises
Company
Bosma Enterprises
Model
71-10403
Catalog number
71-10403
Device description
Latex Textured Powder Free Exam Gloves Large 100/Box
Published
2021-07-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYYLatex Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120692000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120692000LATEX EXAMINATION GLOVES (POWDER FREE)Top Calibre Sdn Bhd2012-05-14LYY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50818634020104PackageGS110In Commercial Distribution
40818634020107PrimaryGS10
00818634020109Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081863402010450818634020104
4081863402010740818634020107
00818634020109008186340201098186340201090818634020109

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-362-5463kimm@bosma.org

Regulatory Flags#

DUNS number
878070325
Device count
100
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818634025487Bosma Enterprises72-5080072-508002025-08-25
10818634025606C.R. Bard10-01011210-0101122026-05-14
10818634025613C.R. Bard10-01011410-0101142026-05-14
10818634025620C.R. Bard10-01011610-0101162026-05-14
10818634025637C.R. Bard10-01011810-0101182026-05-14
10818634025644C.R. Bard10-01012010-0101202026-05-14
10818634025651C.R. Bard10-12061010-1206102026-05-14
10818634025668C.R. Bard10-12061210-1206122026-05-14
10818634025675C.R. Bard10-12061410-1206142026-05-14
10818634025682C.R. Bard10-12061610-1206162026-05-14
10818634025699C.R. Bard10-12061810-1206182026-05-14
10818634025705C.R. Bard10-12062010-1206202026-05-14
00818634020635Bosma Enterprises10-8020PAO10-8020PAO2026-05-14
00818634025210Bosma Enterprises10-9030WIL10-9030WIL2026-05-14
00818634025838Bosma Enterprises10-9030WI210-9030WI22026-05-14
00818634026040Bosma Enterprises10-8020SAL210-8020SAL22026-05-14
10818634021387Gammex71-851171-85112021-07-01
10818634021394Gammex71-851271-85122021-07-01
10818634021400Gammex71-851371-85132021-07-01
10818634021417Gammex71-851471-85142021-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884389108362CURADMEDLINE INDUSTRIES, INC.LYY2026-10-29
00888277187088CURADMEDLINE INDUSTRIES, INC.LYY2026-10-29
00755676002642mvetADI MedicalLYY2026-10-23
00755676002659mvetADI MedicalLYY2026-10-23
00755676002703mvetADI MedicalLYY2026-10-23
00755676002734mvetADI MedicalLYY2026-10-23
00616784245119SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, AmbidextrousDynarex CorporationLYY2026-10-01
00616784245218SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, AmbidextrousDynarex CorporationLYY2026-10-01
00616784671628SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, AmbidextrouDynarex CorporationLYY2026-09-30
00616784671727SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, AmbidextrousDynarex CorporationLYY2026-09-30
00616784671826SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, AmbidextrousDynarex CorporationLYY2026-09-30
00616784671925SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, AmbidextrousDynarex CorporationLYY2026-09-30
00021130794461Signature CareBETTER LIVING BRANDS LLCLYY2026-07-16
10850015055871TOUGHGRIP 7 MIL LATEX GLOVES-LULINE, INC.LYY2026-07-14
10850015055888TOUGHGRIP 7 MIL LATEX GLOVES-MULINE, INC.LYY2026-07-14
10850015055895TOUGHGRIP 7 MIL LATEX GLOVES-SULINE, INC.LYY2026-07-14
10850015055901TOUGHGRIP 7 MIL LATEX GLOVES-XULINE, INC.LYY2026-07-14
10850015055918EXT CUFF 12 MIL LATEX GLOVES-LULINE, INC.LYY2026-07-10
10850015055925EXT CUFF 12 MIL LATEX GLOVES-MULINE, INC.LYY2026-07-10
10850015055932EXT CUFF 12 MIL LATEX GLOVES-SULINE, INC.LYY2026-07-10
10850015055949EXT CUFF 12 MIL LATEX GLOVES-XULINE, INC.LYY2026-07-10
10076490456525TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10076490456532TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10076490456549TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10076490456556TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10810141931715VIVIT SupplyVivit Supply LLCLYY2024-05-17
10810141931722VIVIT SupplyVivit Supply LLCLYY2024-05-17
10810141931746VIVIT SupplyVivit Supply LLCLYY2024-05-17
10810141931739VIVIT SupplyVivit Supply LLCLYY2024-05-17
09555002101053AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08