FDA.reportPublic FDA data

Scott's Select Latex Gloves

Primary DI
D77835086301
Brand
Scott's Select Latex Gloves
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
350-8630
Catalog number
350-8630
Device description
Powder Free Latex Exam Gloves, size Extra Small. Features & Benefits: Smooth polymer interior coating, dry and moist donning efficiency, consistent grip in all operating conditions, protein-rated to minimize exposure to allergens and irritants, micro-textured, non-sterile. 100 gloves per box, 10 boxes per case.For more information visit https://www.scottsdental.com/latex-gloves-scotts-select.html?queryID=27ca912dce0562d5c50ee2eb70b0ece0&objectID=23941&indexName=magento2_production_default_products
Published
2024-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
K052666000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052666000NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEINAscend Eagle, Inc.2006-01-25LYY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D77835086302PackageHIBCC10In Commercial Distribution
D77835086301PrimaryHIBCC0
D77835086300Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment 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 during patient examination/treatment or for other sanitary purposes; 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 various contamination. 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.

Contacts#

Phone, Email table
PhoneEmail
(800) 901-3368info@scottsdental.com

Regulatory Flags#

DUNS number
137217043
Device count
100
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D77819910111SCOTT'S SELECT 37% ETCH GEL 1.2ml SYRINGE KIT 4/pk199-1011199-10112017-05-24
D77819910121SCOTT'S SELECT 37% ETCH GEL 12gm BULK SYRINGE KIT199-1012199-10122017-05-24
D77819910131SCOTT'S SELECT 37% ETCH GEL 50mL JUMBO SYRINGE KIT199-1013199-10132017-05-24
D77819910141SCOTT'S SELECT 37% ETCH GEL 50mL JUMBO SYRINGE199-1014199-10142017-05-24
D77819910081SCOTT'S SELECT AUTOMIX 25ml TEMP CEMENT NE199-1008199-10082017-06-02
D77819910451SCOTT'S SELECT TEMP AUTOMIX NE 11gm199-1045199-10452017-06-02
D77818810880SCOTT'S MORREL CROWN REMOVER w/ 4-TIPS188-1088188-10882021-02-27
D77818820080SCOTT'S CROWN GRABBER REMOVER188-2008188-20082021-02-27
D77818831030SCOTT'S K-STYLE CROWN REMOVER w/ RUBBER TIPS188-3103188-31032021-02-27
D77810702991Scott's Select Non-Woven Sponges 2 x 2 107-0299107-02992024-08-27
D77810704441Scott's Select Non-Woven Sponges 4 x 4107-0444107-04442024-08-27
D77810320011Scott's Select Mirror Handle Cone Socket Octagonal103-2001103-20012024-09-05
D77810320021Scott's Select Mirror Handle Cone Socket Round103-2002103-20022024-09-05
D77810320031Scott's Select Mouth Mirror Front Surface #3103-2003103-20032024-09-05
D77810320041Scott's Select Mouth Mirror Front Surface #4103-2004103-20042024-09-05
D77810320051Scott's Select Mouth Mirror Front Surface #5103-2005103-20052024-09-05
D77810750051"SCOTT'S SYRINGE SLEEVE 2.5""x10"" (500) CLEAR"107-5005107-50052021-02-27
D77810750061"SCOTT'S SYRINGE SLEEVE 2.5""x10"" (500) BLUE"107-5006107-50062021-02-27
D77810750071"SCOTT'S FULL CHAIR COVER 29"" X 80"" (125/bx)"107-5007107-50072021-02-27
D77810750091"SCOTT'S HALF CHAIR CVR 27.5"" X 24"" (225/bx)"107-5009107-50092021-02-27

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