FDA.reportPublic FDA data

THE SAFETY ZONE

Primary DI
B340GREPXL1
Brand
THE SAFETY ZONE
Company
IMPACT PRODUCTS, LLC
Model
GREP-XL-1
Catalog number
B340GREP-XL-1
Device description
Small Latex Powder Free Exam Glove
Published
2023-06-16
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
LYYLatex Patient Examination Glove

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022016000POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVETop Glove Medical (Thailand) Co., Ltd.2002-10-15LYY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B340GREPXL1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

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
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
B340791960L1NA791960L7919602020-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00021130794461Signature CareBETTER LIVING BRANDS LLCLYY2026-07-16
10850015055871TOUGHGRIP 7 MIL LATEX GLOVES-LULINE, INC.LYY2026-07-14
10850015055888TOUGHGRIP 7 MIL LATEX GLOVES-MULINE, INC.LYY2026-07-14
10850015055895TOUGHGRIP 7 MIL LATEX GLOVES-SULINE, INC.LYY2026-07-14
10850015055901TOUGHGRIP 7 MIL LATEX GLOVES-XULINE, INC.LYY2026-07-14
10850015055918EXT CUFF 12 MIL LATEX GLOVES-LULINE, INC.LYY2026-07-10
10850015055925EXT CUFF 12 MIL LATEX GLOVES-MULINE, INC.LYY2026-07-10
10850015055932EXT CUFF 12 MIL LATEX GLOVES-SULINE, INC.LYY2026-07-10
10850015055949EXT CUFF 12 MIL LATEX GLOVES-XULINE, INC.LYY2026-07-10
10076490456525TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10076490456532TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10076490456549TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10076490456556TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10810141931715VIVIT SupplyVivit Supply LLCLYY2024-05-17
10810141931722VIVIT SupplyVivit Supply LLCLYY2024-05-17
10810141931746VIVIT SupplyVivit Supply LLCLYY2024-05-17
10810141931739VIVIT SupplyVivit Supply LLCLYY2024-05-17
09555002101053AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101060AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101077AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101084AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101091AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101404AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101411AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101428AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101435AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101442AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101558AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101565AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101572AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08