FDA.reportPublic FDA data

Bodyguard

Primary DI
00662956813792
Brand
Bodyguard
Company
Fastenal Company
Model
S-805E
Device description
S Series 805E 5 mil Cream Latex Exam Grade Powder Free Body Guard® Disposable Glove
Published
2023-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K111923000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111923000SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILEPt. Intan Hevea Industry2011-11-04LYY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30662956957695PackageGS1100In Commercial Distribution
50662956957699PackageGS110In Commercial Distribution
00662956813792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3066295695769530662956957695
5066295695769950662956957699
00662956813792006629568137926629568137920662956813792

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Regulatory Flags#

DUNS number
042653634
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00662956500463BodyguardL-816E2025-02-21
00662956500432BodyguardS-814E2025-02-21
00662956500456BodyguardM-816E2025-02-21
00662956500470BodyguardXL-814E2025-02-21
30662956500433BodyguardS-814E2025-02-21
30662956500457BodyguardM-816E2025-02-21
30662956500464BodyguardL-816E2025-02-21
30662956500471BodyguardXL-816E2025-02-21
00662956390040Bodyguard815 BK M2023-05-24
00662956390316Bodyguard815 BK S2023-05-24
00662956483216Bodyguard815 BK XL2023-05-24
00662956211550Bodyguard816EI VP2023-05-24
30662956935563Bodyguard815 BK M2023-05-24
00662956390170Bodyguard815 BK L2023-05-24
30662956935556Bodyguard815 BK S2023-05-24
30662956935570Bodyguard815 BK XL2023-05-24
00662956190213Bodyguard816EI2023-05-18
03066295694406Bodyguard816EI2023-05-18
30662956992078Bodyguard814E- L2023-01-24
30662956992085Bodyguard814E- M2023-01-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
09555002101060AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101077AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101084AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101091AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101404AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101411AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101428AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101435AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101442AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101558AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101565AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101572AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08