FDA.reportPublic FDA data

Diversamed

Primary DI
B3408641L1
Brand
Diversamed
Company
IMPACT PRODUCTS, LLC
Model
8641L
Catalog number
8641L
Device description
Small Nitrile Power Free Exam Glove
Published
2020-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K152517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152517000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3408641L1PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005052360
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B3402517650Naturelle2517652017-01-26
10729661269348Naturelle25160273251602732024-02-01
10729661269447Naturelle25176488251764882024-02-01
10729661269454Naturelle25176598251765982024-02-01
B340GREPLG1The Safety ZoneGREP-LG-1GREP-LG-12023-06-16
B340GREPMD1The Safety ZoneGREP-MD-1GREP-MD-12023-06-16
B340GREPSM1THE SAFETY ZONEGREP-SM-1B340GREP-SM-12023-06-16
B340GREPXL1THE SAFETY ZONEGREP-XL-1B340GREP-XL-12023-06-16
B340790069L1NA790069L7900692020-06-26
B340790072S1NA790072S7900722020-06-26
B340790073M1NA790073XL7900732020-06-26
B3407900ML1NA790071M7900712020-06-26
B340790222S1NA790222S7902222020-06-26
B340790223M1NA790223M7902232020-06-26
B340790224L1NA790224L7902242020-06-26
B340790226XL1NA790226XL7902262020-06-26
B340790371M1NA790371M7903712020-06-26
B340790372L1NA790372L7903722020-06-26
B340791950S1NA791950S7919502020-06-26
B340791955M1NA791955M7919552020-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00366975073341BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073358BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073365BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
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
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
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00755676002529mvetADI MedicalLZA2026-10-23
00755676002550mvetADI MedicalLZA2026-10-23
00755676002581mvetADI MedicalLZA2026-10-23
00755676002611mvetADI MedicalLZA2026-10-23
00755676002765mvetADI MedicalLZA2026-10-23
00755676002796mvetADI MedicalLZA2026-10-23
00755676002826mvetADI MedicalLZA2026-10-23
00755676002857mvetADI MedicalLZA2026-10-23
00755676002994mvetADI MedicalLZA2026-10-23