FDA.reportPublic FDA data

SHOWA

Primary DI
00038054256180
Brand
SHOWA
Company
SHOWA BEST GLOVE, INC.
Model
M
Catalog number
5005PFM
Device description
"Latex PF Exam , polymer coated, low protein, natural rubber latex, 9.5""/240mm, rolled cuff, bisque grip, M"
Published
2023-03-24
Public version status
New
Distribution status
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10038054256187PackageGS110In Commercial Distribution
00038054256180PrimaryGS10
20038054256184Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003805425618710038054256187
00038054256180000380542561800380542561800038054256180
2003805425618420038054256184

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical glove, non-powdered, antimicrobialA device containing Hevea natural rubber latex (NRL) [e.g., NRL/polymer composite] intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; it includes an antimicrobial or antiviral agent/properties intended to reduce viable-microbe exposure in case of sharp penetration and its inner surface is not covered with powder. It is used mainly as a two-way barrier to protect both the patient and the staff against 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.

Contacts#

Phone, Email table
PhoneEmail
800-241-0323USA@Showagroup.com

Regulatory Flags#

DUNS number
807930412
Device count
100
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00038054654306DermaThinXLM7002PFXL2023-03-31
00038054654313DermaThinXXLM7002PFXXL2023-03-31
00038054654375DermaThinSM7002PFS2023-03-31
00038054654382DermaThinMM7002PFM2023-03-31
00038054654399DermaThinLM7002PFL2023-03-31
10038054654303DermaThinXLM7002PFXL2023-03-31
10038054654310DermaThinXXLM7002PFXXL2023-03-31
00038054654368DermaThinXSM7002PFXS2023-03-31
10038054654372DermaThinSM7002PFS2023-03-31
10038054654389DermaThinMM7002PFM2023-03-31
10038054654396DermaThinLM7002PFL2023-03-31
00038054256104SHOWAXL5005PFXL2023-03-24
00038054256111SHOWAXXL5005PFXXL2023-03-24
00038054256166SHOWAXS5005PFXS2023-03-24
00038054256173SHOWAS5005PFS2023-03-24
00038054256197SHOWAL5005PFL2023-03-24
10038054256101SHOWAXL5005PFXL2023-03-24
10038054256118SHOWAXXL5005PFXXL2023-03-24
10038054256163SHOWAXS5005PFXS2023-03-24
10038054256170SHOWAS5005PFS2023-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
09555002101589AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101596AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
10810141931319VIVIT SupplyVivit Supply LLCLYY2023-12-22
10810141931326VIVIT SupplyVivit Supply LLCLYY2023-12-22
10810141931333VIVIT SupplyVivit Supply LLCLYY2023-12-22
10810141931340VIVIT SupplyVivit Supply LLCLYY2023-12-22
10810141931357VIVIT SupplyVivit Supply LLCLYY2023-12-22
G331COAP215S21Technigrip Powder Free Latex Exam GlovesTotal Source ManufacturingLYY2023-12-13
G331COAP220S2SureGrip Latex Powder Free Exam GlovesTotal Source ManufacturingLYY2023-12-13