FDA.reportPublic FDA data

The Orthodontic Store

Primary DI
10843471135003
Brand
The Orthodontic Store
Company
Young Innovations, Inc.
Model
25084
Catalog number
25084
Device description
Trufit™ Green Ultrathin Chloroprene Gloves -Small
Published
2022-11-02
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843471135003PackageGS1100In Commercial Distribution
20843471135000PackageGS110In Commercial Distribution
00843471135006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084347113500310843471135003
2084347113500020843471135000
00843471135006008434711350068434711350060843471135006

GMDN Terms#

Term, Definition table
TermDefinition
Polychloroprene examination/treatment glove, non-powderedA non-sterile device made of polychloroprene (neoprene) 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 talcum powder and it does not have antimicrobial features. 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/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

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 558-6684support@youngspecialties.com

Regulatory Flags#

DUNS number
004193103
Device count
1
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840326426630Astek1002991002992026-05-11
00840326423851Astek19025190252025-03-17
00840326423868Astek19026190262025-03-17
00840326423875Astek19027190272025-03-17
00840326423882Astek19028190282025-03-17
00843471150061Astek19000190002022-10-18
00843471150078Astek19005190052022-10-18
00843471150085Astek19001190012022-10-18
00843471150092Astek19006190062022-10-18
00840326426586Plak Smacker2000622026-04-20
00840326426593Plak Smacker2000632026-04-20
00840326426609Plak Smacker2000642026-04-20
00840326426616Plak Smacker2000652026-04-20
00840326426623Plak Smacker2000662026-04-20
00840326426203Young Specialties2000-02-102000-02-102026-01-26
00840326426210Young Specialties2000-03-102000-03-102026-01-26
00840326426227Young Specialties2000-04-102000-04-102026-01-26
00840326426234Young Specialties2000-05-102000-05-102026-01-26
00840326426241Young Specialties2000-06-102000-06-102026-01-26
00840326426258Young Specialties2000-07-102000-07-102026-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08859185202172mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202189mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202196mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202202mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202219mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209249Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209256Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209263Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209270Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209287Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209294Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209300Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209317Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209324Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209331Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
09551006060525NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060532NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060549NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060556NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060563NITRILECARE PREMIUMCAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060624NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060631NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060648NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060655NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060662NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060822NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061225NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061249CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061256CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061263CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08