FDA.reportPublic FDA data

SMC Blue

Primary DI
20860003676107
Brand
SMC Blue
Company
Southland Medical, LLC
Model
SMCB-S
Catalog number
SMCB-S
Device description
SMC Blue PF Latex Exam Gloves, Small, 50/bx, 10bxs/cs
Published
2022-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
20860003676107PackageGS110In Commercial Distribution
00860003676103PrimaryGS10
70860003676102Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086000367610720860003676107
00860003676103008600036761038600036761030860003676103
7086000367610270860003676102

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-959-9160terry@southlandmed.com

Regulatory Flags#

DUNS number
782216881
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003676103SMC BlueSMCB-SSMCB-S2022-09-05
00860003676127SMC BlueSMCB-MSMCB-M2022-09-05
00860003676141SMC BlueSMCB-LSMCB-L2022-09-05
00860003676158SMC BlueSMCB-XLSMCB-XL2022-09-05
10860003676124SMC BlueSMCB-MSMCB-M2022-09-05
10860003676148SMC BlueSMCB-LSMCB-L2022-09-05
10860003676155SMC BlueSMCB-XLSMCB-XL2022-09-05

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
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
G331COAP215S21Technigrip Powder Free Latex Exam GlovesTotal Source ManufacturingLYY2023-12-13
G331COAP220S2SureGrip Latex Powder Free Exam GlovesTotal Source ManufacturingLYY2023-12-13
G331COAP315M2Technigrip Powder Free Latex Exam GlovesTotal Source ManufacturingLYY2023-12-13
G331COAP330M2SureGrip Latex Powder Free Exam GlovesTotal Source ManufacturingLYY2023-12-13
G331COAP415L2Technigrip Powder Free Latex Exam GlovesTotal Source ManufacturingLYY2023-12-13
G331COAP440L2SureGrip Latex Powder Free Exam GlovesTotal Source ManufacturingLYY2023-12-13
G331COAP515XL2Technigrip Powder Free Latex Exam GlovesTotal Source ManufacturingLYY2023-12-13
G331COAP550XL2SureGrip Latex Powder Free Exam GlovesTotal Source ManufacturingLYY2023-12-13
09551006060129RUBBERCARE LATEX PFCAREGLOVE GLOBAL SDN. BHD.LYY2023-11-24
09551006060136RUBBERCARE LATEX PFCAREGLOVE GLOBAL SDN. BHD.LYY2023-11-24
09551006060143RUBBERCARE LATEX PFCAREGLOVE GLOBAL SDN. BHD.LYY2023-11-24