FDA.reportPublic FDA data

MediChoice

Primary DI
50885632136403
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
GLV2302
Device description
Glove Exam Nitrile Xt Next Generation 9.5-Inch Cuff Medium Non-Sterile Ambidextrous Powder-Free Textured Beaded Cuff Disposable Cleared For Use With Some Chemotherapy Drugs Not Made With Natural Rubber Latex MediChoice
Published
2020-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LZCPatient examination glove, specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885632136403PackageGS110In Commercial Distribution
30885632136409PrimaryGS10
10885632136405Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088563213640350885632136403
3088563213640930885632136409
1088563213640510885632136405

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00Store under cool, dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight, fluorescent lighting or other source of ozone.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007941230
Device count
200
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
10885632434266Halyard563482026-05-22
10885632434303Halyard563522026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22
10885632468520Halyard614892026-05-22
10885632509032Halyard620732026-05-22
10885632509049Halyard620742026-05-22
10885632509056Halyard620752026-05-22
10885632509063Halyard620762026-05-22
10885632510199Halyard620772026-05-22
10885632521751SurgiTrackSM450130D17D2026-05-22
10885632517105SurgiTrackSM4500410F102026-03-23
10885632516429SurgiTrackSM4500309F242026-03-17
30885632495469HalyardIDSG10012026-03-13
20885632495851HalyardIDSG10022026-03-13
20885632495868HalyardIDSG10032026-03-13
20885632495875HalyardIDSG10042026-03-13
20885632495882HalyardIDSG10052026-03-13
20885632496742HalyardIDSG10062026-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850006162611Aloe-ShieldClinical Supply CompanyLZC2026-03-24
00850006162628Aloe-ShieldClinical Supply CompanyLZC2026-03-24
00850006162796Aloe-ShieldClinical Supply CompanyLZC2026-03-24
00850006162758Aloe-ShieldClinical Supply CompanyLZC2026-03-24
00850006162765Aloe-ShieldClinical Supply CompanyLZC2026-03-24
30680651489532HalyardO&M HALYARD, INC.LZC2026-03-12
00810194400278AiraAIRA, LLCLZC2026-02-10
00810007662534HANDPROHOURGLASS INTERNATIONAL INCLZC2025-12-15
00810007662541HANDPROHOURGLASS INTERNATIONAL INCLZC2025-12-15
00810007662558HANDPROHOURGLASS INTERNATIONAL INCLZC2025-12-15
00810007662565HANDPROHOURGLASS INTERNATIONAL INCLZC2025-12-15
00810007662572HANDPROHOURGLASS INTERNATIONAL INCLZC2025-12-15
00810007662602HANDPROHOURGLASS INTERNATIONAL INCLZC2025-12-15
00847713001340microdot® FlexCambridge Sensors USA LLCLZC2025-12-12
00847713001258microdot® FlexCambridge Sensors USA LLCLZC2025-12-12
10842942014151PRIMEDpriMED Medical Products IncLZC2025-11-18
40080196334255MEDLINEMEDLINE INDUSTRIES, INC.LZC2025-07-17
00810194400261AiraAIRA, LLCLZC2025-07-16
00850061859174GCB Medical SupplyGCB MEDICAL LLCLZC2025-07-09
00850061859082GCB Medical SupplyGCB MEDICAL LLCLZC2025-07-09
00850061859198GCB Medical SupplyGCB MEDICAL LLCLZC2025-07-09
20076490730592KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490748658KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490754888KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490755069KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490763101KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490763743KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490768878KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490723617KIMTECHAnsell Healthcare ProductLZC2025-07-02
20076490730158KIMTECHAnsell Healthcare ProductLZC2025-07-02