FDA.reportPublic FDA data

SemperForce Nitrile Exam Glove

Primary DI
00841277101058
Brand
SemperForce Nitrile Exam Glove
Company
Harps USA, Inc.
Model
BKNF103
Catalog number
BKNF103
Device description
SemperForce Nitrile Exam Glove, size M
Published
2020-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
00841277101058PrimaryGS10
00841277103465Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841277101058008412771010588412771010580841277101058
00841277103465008412771034658412771034650841277103465

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004072158
Device count
100
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