FDA.reportPublic FDA data

SAFARI

Primary DI
10723860862256
Brand
SAFARI
Company
Mexpo International Inc.
Model
SFR 86225-LTX-PF
Catalog number
SFR 86225-LTX-PF
Device description
LATEX EXAMINATION GLOVES POWDER FREE (X-SMALL)
Published
2022-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00723860862259PrimaryGS10
10723860862256Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00723860862259007238608622597238608622590723860862259
1072386086225610723860862256

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

Regulatory Flags#

DUNS number
779982974
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
00723860973252BLOSSOMBM 97325-CHL-LG-PFBM 97325-CHL-LG-PF2022-02-23
00723860973269BLOSSOMBM 97326-CHL-LG-PFBM 97326-CHL-LG-PF2022-02-23
00723860973276BLOSSOMBM 97327-CHL-LG-PFBM 97327-CHL-LG-PF2022-02-23
00723860973283BLOSSOMBM 97328-CHL-LG-PFBM 97328-CHL-LG-PF2022-02-23
00723860973290BLOSSOMBM 97329-CHL-LG-PFBM 97329-CHL-LG-PF2022-02-23
00723860977151BLOSSOMBM 97715-CHL-P-PFBM 97715-CHL-P-PF2022-02-23
00723860977168BLOSSOMBM 97716-CHL-P-PFBM 97716-CHL-P-PF2022-02-23
00723860977175BLOSSOMBM 97717-CHL-P-PFBM 97717-CHL-P-PF2022-02-23
00723860977182BLOSSOMBM 97718-CHL-P-PFBM 97718-CHL-P-PF2022-02-23
00723860977199BLOSSOMBM 97719-CHL-P-PFBM 97719-CHL-P-PF2022-02-23
00723860013323BLOSSOMBM 1355-RD DAMBM 1355-RD DAM2023-06-16
00723860013347BLOSSOMBM 1366-RD DAMBM 1366-RD DAM2023-06-16
00723860013668BLOSSOMBM1366B-RD DAMBM1366B-RD DAM2023-06-16
00723860014559BLOSSOMBM1355B-RD DAMBM1355B-RD DAM2023-06-16
00723860015556BLOSSOMBM 1555-RD DAM BLKBM 1555-RD DAM BLK2023-06-16
00723860015662BLOSSOMBM 1566-RD DAM BLKBM 1566-RD DAM BLK2023-06-16
00723860016553BLOSSOMBM1655-RD DAMBM1655-RD DAM2023-06-16
00723860016669BLOSSOMBM 1666-RD DAMBM 1666-RD DAM2023-06-16
10723860013320BLOSSOMBM 1355-RD DAMBM 1355-RD DAM2023-06-16
10723860013344BLOSSOMBM 1366-RD DAMBM 1366-RD DAM2023-06-16

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