FDA.reportPublic FDA data

MediChoice

Primary DI
30885632291375
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
GLV9104
Device description
Glove Exam Nitrile Cobalt Blue 3.8g XLarge Powder Free Textured Finger 180/EA in a BX 10/BX in a CA NonSterile Not Made with Natural Rubber Latex MediChoice
Published
2020-12-02
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

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
30885632291375PackageGS110In Commercial Distribution
20885632291378PrimaryGS10
10885632291371Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088563229137530885632291375
2088563229137820885632291378
1088563229137110885632291371

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 sources of ozone.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007941230
Device count
180
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