FDA.reportPublic FDA data

StarMed Black Nitrile Exam Glove

Primary DI
00841277103168
Brand
StarMed Black Nitrile Exam Glove
Company
Harps USA, Inc.
Model
SPK-SMNB
Catalog number
SPK-SMNB
Device description
StarMed Black Nitrile Exam Glove, sample pack
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151836000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151836000NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACKHartalega NGC Sdn. Bhd.2015-10-21LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841277103168PrimaryGS10
00841277105360Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841277103168008412771031688412771031680841277103168
00841277105360008412771053608412771053600841277105360

Sterilization Methods#

Method table
Method

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 / 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

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Primary DI, Brand, Company table
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00366975073372BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073389BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
10850061371246American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371260American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371284American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371291American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371307American Health and SafetyLabsource, Inc.LZA2026-11-02
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05060655503481Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655504006Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
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