FDA.reportPublic FDA data

Sempermed Syntegra preCision

Primary DI
09001570557919
Brand
Sempermed Syntegra preCision
Company
Harps USA, Inc.
Model
SPR750
Catalog number
SPR750
Device description
Polyisoprene Surgical Glove PF - 7.5
Published
2026-05-21
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09001570557919PrimaryGS10
09001570557902Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09001570557919090015705579199001570557919
09001570557902090015705579029001570557902

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
00841277110951Novera CloudNVSFB0404 / NVSFOB0404NVSFOB04042026-10-30
00841277110975Novera CloudNVSFB0606 / NVSFOB0606NVSFOB06062026-10-30
00841277111040Novera CloudNVSFS0707 / NVSFO0707NVSFO07072026-10-30
00841277111064Novera CloudNVSFS0909 / NVSFO9292NVSFO92922026-10-30
00841277111088Novera CloudNVSFB0303 / NVSFOB0303NVSFOB03032026-10-30
00841277111101Novera BreezeNVHMF0203 / NVFLM2228NVFLM22282026-10-30
00841277111125Novera BreezeNVHMF0405 / NVFLM0447NVFLM04472026-10-30
00841277111149Novera BreezeNVHMR0203 / NVFLMR2228NVFLMR22282026-10-30
00841277111163Novera BreezeNVHMR0405 / NVFLMR0447NVFLMR04472026-10-30
00841277111309Novera SeamNVPOP0205 / NVPOP2405NVPOP24052026-10-30
00841277111347Novera LockNVCHI0405 / NVCHD0448NVCHI04052026-10-30
00841277111361Novera RenewNVAGA0606 / NVAGAL0606NVAGA06062026-10-30
00841277111378Novera SeamNVGOP0406NVAGOP04062026-10-14
00841277111392Novera SeamNVGOP0410NVAGP04102026-10-14
00841277111408Novera SeamNVGOP0410NVAGOP04102026-10-14
00841277111248Novera BalanceNVHYGE025GNVHYGE025G2026-09-04
00841277111286Novera SeamNVPOP1004NVPOP10042026-09-04
00841277111187Novera RenewNVAGAL0202NVAGAL02022026-08-26
00841277111200Novera RenewNVAGAL0448NVAGAL04482026-08-26
00841277111224Novera RenewNVAGAR0112NVAGAR01122026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850061371246American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371260American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371284American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371291American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371307American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371314American Health and SafetyLabsource, Inc.LZC2026-11-02
07333350064938Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
07333350119621Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-10-29
07333350176181Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
07333350407926Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-10-29
07333350581305Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-10-29
07333350696177Biogel® PI MicroMölnlycke Health Care ABKGO2026-10-29
07333350861582Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
07333350974121Biogel® PI MicroMölnlycke Health Care ABKGO2026-10-29
07333350999124Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
10809160542118HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-28
10809160542125HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-10-28
10809160542132HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-10-28
00755676002369mvetADI MedicalKGO2026-10-26
00755676002376mvetADI MedicalKGO2026-10-26
00755676002413mvetADI MedicalKGO2026-10-26
00755676002437mvetADI MedicalKGO2026-10-26
00755676002451mvetADI MedicalKGO2026-10-26
00755676002468mvetADI MedicalKGO2026-10-26
00755676002482mvetADI MedicalKGO2026-10-26
00755676002505mvetADI MedicalKGO2026-10-26
10809160541722HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
10809160541746HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
10809160541753HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23