FDA.reportPublic FDA data

NA

Primary DI
B340791965XL1
Brand
NA
Company
IMPACT PRODUCTS, LLC
Model
791965XL
Catalog number
791965
Device description
Latex Powder Free Exam Glove - XLarge
Published
2020-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LYZVinyl Patient Examination Glove

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982872000TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)Tg Medical Sdn. Bhd.1998-10-15LYY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B340791965XL1PrimaryHIBCC0

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
00810160182955SupmedicSupmedics Inc.LYZ2026-11-05
00884389108393CURADMEDLINE INDUSTRIES, INC.LYZ2026-10-29
00199536905610BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905627BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905634BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905641BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905658BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00850084857218MedClickMedClick LLCLYZ2026-07-22
00850084857225MedClickMedClick LLCLYZ2026-07-22
00850084857232MedClickMedClick LLCLYZ2026-07-22
00850084857249MedClickMedClick LLCLYZ2026-07-22
00850084857256MedClickMedClick LLCLYZ2026-07-22
00850084857263MedClickMedClick LLCLYZ2026-07-22
00850084857270MedClickMedClick LLCLYZ2026-07-22
00850084857287MedClickMedClick LLCLYZ2026-07-22
00850084857294MedClickMedClick LLCLYZ2026-07-22
00850084857300MedClickMedClick LLCLYZ2026-07-22
00850084857317MedClickMedClick LLCLYZ2026-07-22
00850084857324MedClickMedClick LLCLYZ2026-07-22
00080196515939CURADMEDLINE INDUSTRIES, INC.LYZ2026-07-06
00810145952054NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952061NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952078NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952085NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952092NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00713733712835MeijerMEIJER, INC.LYZ2026-06-05
10840330701911ProCureTwin Med, LLCLYZ2026-05-27
10840330701928ProCureTwin Med, LLCLYZ2026-05-27
10840330701935ProCureTwin Med, LLCLYZ2026-05-27
10840330701942ProCureTwin Med, LLCLYZ2026-05-27