FDA.reportPublic FDA data

Scott's Select Nitrile Gloves

Primary DI
D77835054990
Brand
Scott's Select Nitrile Gloves
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
350-5499
Catalog number
350-5499
Device description
Nitrile Powder Free Exam Gloves, size Extra Small. Features & Benefits: Super soft and stretchy formulation, provides natural feel, superior tactile sensitivity, textured fingertip provides exceptional grip, 300 per box, 10 boxes per case. For more information visit https://www.scottsdental.com/scotts-select-nitrile-gloves.html?queryID=617090b7aff0499e933ca4b49c1fa586&objectID=32034&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
Rx
false
OTC
false
Sterile
false
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
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
D77835054992PackageHIBCC10In Commercial Distribution
D77835054991PrimaryHIBCC0
D77835054990Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile 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 patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
137217043
Device count
300
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
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20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
00194346693122EquateWAL-MART STORES, INC.LZA2026-06-02
00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
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00768627017312Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
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10840330702239ProCureTwin Med, LLCLZA2026-06-01
10840330702246ProCureTwin Med, LLCLZA2026-06-01
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10840330706763ProCureTwin Med, LLCLZA2026-06-01
10840330706770ProCureTwin Med, LLCLZA2026-06-01
10840330706787ProCureTwin Med, LLCLZA2026-06-01