FDA.reportPublic FDA data

Sempermed Syntegra Green

Primary DI
09001570557315
Brand
Sempermed Syntegra Green
Company
Harps USA, Inc.
Model
SGR600
Catalog number
SGR600
Device description
Polyisoprene Surgical Glove PF - 6.0
Published
2026-02-12
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1
LZCMedical Glove, SpecialtyGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250313000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250313000Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbH2025-08-19KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09001570557315PrimaryGS10
00841277110807Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
09001570557315090015705573159001570557315
00841277110807008412771108078412771108070841277110807

GMDN Terms#

Term, Definition table
TermDefinition
Polychloroprene surgical glove, non-powderedA 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 powder and it does not include antimicrobial agents/materials. 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.

Contacts#

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

Regulatory Flags#

DUNS number
004072158
Device count
50
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841277111392Novera SeamNVGOP0410NVGOP04102026-10-14
10841277111382Novera SeamNVGOP0406NVGOP04062026-10-14
00841277111248Novera BalanceNVHYGE025GNVHYGE025G2026-09-04
00841277111286Novera SeamNVPOP1004NVPOP10042026-09-04
00841277111187Novera RenewNVAGAL0202NVAGA0202 / NVAGAL02022026-08-26
00841277111200Novera RenewNVAGAL0448NVAGA0405 / NVAGAL04482026-08-26
00841277111224Novera RenewNVAGAR0112NVAGR0112 / NVAGAR01122026-08-26
00841277111323Novera RenewNVCHD0448NVCHI0405 / NVCHD04482026-08-26
00841277111378Novera SeamNVGOP0406NVGOP04062026-10-14
00841277111385Novera SeamNVGOP0406NVGOP04062026-10-14
00841277111408Novera SeamNVGOP0410NVGOP04102026-10-14
10841277111405Novera SeamNVGOP0410NVGOP04102026-10-14
00841277111262Novera RenewNVCOL0202NVCOL02022026-08-26
09001570557278Sempermed Syntegra GreenSGR550SGR5502026-05-21
09001570557308Sempermed Syntegra GreenSGR600SGR6002026-05-21
09001570557339Sempermed Syntegra GreenSGR650SGR6502026-05-21
09001570557360Sempermed Syntegra GreenSGR700SGR7002026-05-21
09001570557391Sempermed Syntegra GreenSGR750SGR7502026-05-21
09001570557421Sempermed Syntegra GreenSGR800SGR8002026-05-21
09001570557452Sempermed Syntegra GreenSGR850SGR8502026-05-21

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Primary DI, Brand, Company table
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