FDA.reportPublic FDA data

MEDLINE

Primary DI
00888277172015
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
SG310
Catalog number
SG310
Device description
GLOVE,EXAM,PF,NITRILE,SMARTGUARD,XSMALL
Published
2024-05-02
Public version status
Update
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
LZAPolymer patient examination glove
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40888277172013PackageGS110In Commercial Distribution
00888277172015PrimaryGS10
10888277172012Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4088827717201340888277172013
00888277172015008882771720158882771720150888277172015
1088827717201210888277172012

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile 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 patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
250
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884389112090MEDLINEEQX7012EQX70122026-10-09
10884389931967MEDLINEMSC7366EPMSC7366EP2026-10-09
20193489079804MEDLINEBNS128632BNS1286322026-10-09
30193489079726MEDLINEBNS111718BNS1117182026-10-09
30193489079771MEDLINEBNS119386BNS1193862026-10-09
30193489079788MEDLINEBNS119387BNS1193872026-10-09
30193489079795MEDLINEBNS120988BNS1209882026-10-09
10197344104116MEDLINEPIVBCA18125PIVBCA181252025-02-06
10197344104130MEDLINEPIVBCA20100PIVBCA201002025-02-06
10197344104147MEDLINEPIVBCA20125PIVBCA201252025-02-06
20197344024992MedlineMPH22325HCGMPH22325HCG2024-03-11
10197344042388HUDSON RCIHUD1895HUD18952026-10-08
10197344042395HUDSON RCIHUD1896HUD18962026-10-08
10653160394273MEDLINEDYND71006DYND710062026-10-08
10653160394532MEDLINEDT22100ADT22100A2026-10-08
10653160394594MEDLINEDYNDC3490ADYNDC3490A2026-10-08
10653160394709MEDLINEDYNDC3601DYNDC36012026-10-08
10653160394921MEDLINEDYNDC2850ADYNDC2850A2026-10-08
10653160395119MEDLINEDYNDC2762BDYNDC2762B2026-10-08
10653160395270MEDLINEDYNDC2539DDYNDC2539D2026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10813172023848NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10813172023848NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023855NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023855NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10813172023862NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023862NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10813172023879NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023879NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10810141933931VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933931VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933948VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933948VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933955VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933955VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933962VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933962VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933979VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933979VIVIT SupplyVivit Supply LLCLZA2026-10-07
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00850054870551BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870568BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870575BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870582BAYLAB USABaylab USA, LLCLZA2026-10-01
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00662956203760BodyguardFastenal CompanyLZA2026-09-30
00662956205320Body GuardFastenal CompanyLZA2026-09-30