FDA.reportPublic FDA data

StarMed Black Nitrile Exam Glove

Primary DI
00841277103151
Brand
StarMed Black Nitrile Exam Glove
Company
Harps USA, Inc.
Model
SMNB105
Catalog number
SMNB105
Device description
StarMed Black Nitrile Exam Glove, size XL
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
00841277103151PrimaryGS10
00841277104370Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841277103151008412771031518412771031510841277103151
00841277104370008412771043708412771043700841277104370

Sterilization Methods#

Method table
Method

Contacts#

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

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 / 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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00366975073372BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073389BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
10850061371246American Health and SafetyLabsource, Inc.LZA2026-11-02
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10850061371284American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371291American Health and SafetyLabsource, Inc.LZA2026-11-02
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