FDA.reportPublic FDA data

Sempermed Syntegra CR Chloroprene Surgical Glove

Primary DI
10841277101802
Brand
Sempermed Syntegra CR Chloroprene Surgical Glove
Company
SEMPERMED USA, INC.
Model
SCR750
Catalog number
SCR750
Device description
Sempermed Syntegra CR Chloroprene Surgical Glove, size 7.5
Published
2020-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
10841277101802PackageGS16In Commercial Distribution
00841277101805PrimaryGS10
M125SCR750SecondaryHIBCC0
00841277104196Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084127710180210841277101802
00841277101805008412771018058412771018050841277101805
00841277104196008412771041968412771041960841277104196

GMDN Terms#

Term, Definition table
TermDefinition
Polychloroprene surgical glove, non-powderedA sterile device made of polychloroprene (neoprene) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with talcum powder and it does not have antimicrobial features. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-366-9545Glove.Info@SempermedUSA.com

Regulatory Flags#

DUNS number
004072158
Device count
40
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
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
00841277110739Caracal Velvet XP24477244772025-08-12
00841277110746Caracal Velvet XP24478244782025-08-12
00841277110753Caracal Velvet XP24479244792025-08-12
00841277110760Caracal Velvet XP24480244802025-08-12
00841277110777Caracal Velvet XP24481244812025-08-12
00841277110289Sempermed iconiX bi-fusionICNX 102ICNX 1022025-04-28
00841277110296Sempermed iconiX bi-fusionICNX 103ICNX 1032025-04-28
00841277110302Sempermed iconiX bi-fusionICNX 104ICNX 1042025-04-28
00841277110319Sempermed iconiX bi-fusionICNX 105ICNX 1052025-04-28
00841277110326Sempermed iconiX bi-fusionICNX 106ICNX 1062025-04-28
00841277110395Sempermed iconiX bi-fusionSPK-ICNXSPK-ICNX2025-04-28
00841277110456Sempermed vinyl comfortEVNP101EVNP1012025-04-28
00841277110463Sempermed vinyl comfortEVNP102EVNP1022025-04-28
00841277110470Sempermed vinyl comfort Exam GloveEVNP103EVNP1032025-04-28
00841277110487Sempermed vinyl comfort EVNP104EVNP1042025-04-28
00841277110494Sempermed vinyl comfort Exam GloveEVNP105EVNP1052025-04-28
00841277110555Sempermed syn-stretch Vinyl Exam GloveSCVNP101SCVNP1012025-04-28
00841277110562Semperguard sun-stretch Vinyl Exam GloveSCVNP102SCVNP1022025-04-28
00841277110579Sempermed vinyl syn-stretch Exam GloveSCVNP103SCVNP1032025-04-28
00841277110586Sempermed vinyl syn-stretch Exam GloveSCVNP104SCVNP1042025-04-28

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