FDA.reportPublic FDA data

MEDLINE

Primary DI
20888277629148
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MSG5860
Catalog number
MSG5860
Device description
GLOVE,SURG,SIGNATURE LTX MICR,LTX,PF,6.0
Published
2025-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGOSurgeon's gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277629148PackageGS150In Commercial Distribution
30888277629145PackageGS14In Commercial Distribution
10888277629141PrimaryGS10
80888277629140Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827762914820888277629148
3088827762914530888277629145
1088827762914110888277629141
8088827762914080888277629140

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical 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 at the surgical site; 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 contamination from microorganisms. 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight.
Special Storage Condition, Specify00Protect from freezing, avoid excessive heat. Shield from direct sunlight, fluorescent lighting, x-rays, moisture ad ozone. Keep dry. Keep away from sunlight.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
2
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
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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09001570557278Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557308Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557339Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557360Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557391Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557421Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557452Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557483Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557797Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557827Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557858Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557889Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557919Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557940Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557971Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570558008Sempermed Syntegra preCisionHarps USA, Inc.KGO2026-05-21
09001570557285Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557346Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557377Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557407Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557438Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557469Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570557490Sempermed Syntegra GreenHarps USA, Inc.KGO2026-02-12
09001570536686Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536693Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536709Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536716Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536723Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12
09001570536730Sempermed Syntegra GreenHarps USA, Inc.KGO2025-12-12