FDA.reportPublic FDA data

StarMed Plus/StarMed Select Nitrile Exam Glove

Primary DI
00841277107159
Brand
StarMed Plus/StarMed Select Nitrile Exam Glove
Company
Harps USA, Inc.
Model
SPK-030VB
Catalog number
SPK-030VB
Device description
StarMed Plus/StarMed Select Nitrile Exam Glove, sample pack
Published
2023-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCZU.V. Spectrometry, Primidone
LZAPolymer Patient Examination Glove
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCZU.V. Spectrometry, PrimidoneClinical Toxicology2
LZAPolymer Patient Examination GloveGeneral Hospital1
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841277107159PrimaryGS10
00841277107166Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841277107159008412771071598412771071590841277107159
00841277107166008412771071668412771071660841277107166

Contacts#

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

Regulatory Flags#

DUNS number
004072158
Device count
6
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841277110951Novera CloudNVSFB0404 / NVSFOB0404NVSFB0404 / NVSFOB04042026-10-30
00841277110975Novera CloudNVSFB0606 / NVSFOB0606NVSFB0606 / NVSFOB06062026-10-30
00841277111002Novera CloudNVSFO0404NVSFO04042026-10-30
00841277111026Novera CloudNVSFO0606NVSFO06062026-10-30
00841277111040Novera CloudNVSFS0707 / NVSFO0707NVSFS0707 / NVSFO07072026-10-30
00841277111064Novera CloudNVSFS0909 / NVSFO9292NVSFS0909 / NVSFO92922026-10-30
00841277111088Novera CloudNVSFB0303 / NVSFOB0303NVSFB0303 / NVSFOB03032026-10-30
00841277111101Novera BreezeNVHMF0203 / NVFLM2228NVHMF0203 / NVFLM22282026-10-30
00841277111125Novera BreezeNVHMF0405 / NVFLM0447NVHMF0405 / NVFLM04472026-10-30
00841277111149Novera BreezeNVHMR0203 / NVFLMR2228NVHMR0203 / NVFLMR22282026-10-30
00841277111163Novera BreezeNVHMR0405 / NVFLMR0447NVHMR0405 / NVFLMR04472026-10-30
00841277111309Novera SeamNVPOP0205 / NVPOP2405NVPOP0205 / NVPOP24052026-10-30
00841277111347Novera LockNVCHI0405 / NVCHD0448NVCHI0405 / NVCHD04482026-10-30
00841277111361Novera RenewNVAGA0606 / NVAGAL0606NVAGA0606 / NVAGAL06062026-10-30
00841277111385Novera SeamNVGOP0406NVGOP04062026-10-14
00841277111187Novera RenewNVAGAL0202NVAGA0202 / NVAGAL02022026-08-26
00841277111392Novera SeamNVGOP0410NVAGP0410 / NVAGOP04102026-10-14
00841277111248Novera BalanceNVHYGE025GNVHGE0090 / NVHYGE025G2026-09-04
00841277111286Novera SeamNVPOP1004NVPOP0410 / NVPOP10042026-09-04
10841277111382Novera SeamNVGOP0406NVGOP04062026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850061371246American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371246American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371260American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371260American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371284American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371284American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371291American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371291American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371307American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371307American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371314American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371314American Health and SafetyLabsource, Inc.LZA2026-11-02
05060655503450Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655503467Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655503474Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655503481Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655504006Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00755676002529mvetADI MedicalLZA2026-10-23
00755676002550mvetADI MedicalLZA2026-10-23
00755676002581mvetADI MedicalLZA2026-10-23