FDA.reportPublic FDA data

VR

Primary DI
10855956008092
Brand
VR
Company
POLYCONVERSIONS, INC.
Model
41450
Device description
Sleeve Gloves 11 Mil Medium Green Unlined - Case 100 Ct.
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZBFinger Cot

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZBFinger CotGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855956008092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085595600809210855956008092

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/examination garment kitA collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
825056401
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850054694017VR424102026-03-30
10850054694024VR425102026-03-30
10850054694031VR426102026-03-30
10855956008122VR412802020-09-24
00850054694911Poly-MedPLG-42502023-09-19
00860006079185VR425062021-07-14
00860006079192VR425062021-07-14
00860006079178VR424062021-07-01
10860006079175VR424062021-07-01
00860006079109VR416602020-12-21
00860006079116VR415602020-12-21
00860006079123VR414602020-12-21
00860006079130VR413602020-12-21
00860006079147VR412602020-12-21
10860006079106VR416602020-12-21
10860006079113VR415602020-12-21
10860006079120VR414602020-12-21
10860006079137VR413602020-12-21
10860006079144VR412602020-12-21
00855956008002VR495532020-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810208581761NuCareNuCare LLCLZB2026-02-04
10810208581778NuCareNuCare LLCLZB2026-02-04
10810208581785NuCareNuCare LLCLZB2026-02-04
10810208581792NuCareNuCare LLCLZB2026-02-04
10810208581808NuCareNuCare LLCLZB2026-02-04
10884389105214MedlineMEDLINE INDUSTRIES, INC.LZB2024-03-05
40884389105215MedlineMEDLINE INDUSTRIES, INC.LZB2024-03-05
00057475210229BIOS LivingThermor LtdLZB2023-09-18
20057475210223BIOS LivingThermor LtdLZB2023-09-18
10665973017898Tech-MedDukal LLCLZB2022-12-09
10665973017904Tech-MedDukal LLCLZB2022-12-09
10665973017911Tech-MedDukal LLCLZB2022-12-09
10665973017928Tech-MedDukal LLCLZB2022-12-09
10665973023660Tech-MedDukal LLCLZB2022-12-06
10665973023677Tech-MedDukal LLCLZB2022-12-06
10665973023684Tech-MedDukal LLCLZB2022-12-06
10665973023691Tech-MedDukal LLCLZB2022-12-06
20665973023667Tech-MedDukal LLCLZB2022-12-06
20665973023674Tech-MedDukal LLCLZB2022-12-06
20665973023681Tech-MedDukal LLCLZB2022-12-06
20665973023698Tech-MedDukal LLCLZB2022-12-06
00814889010377Front LineProstat First Aid, LLCLZB2022-10-28
00814889013781Front LineProstat First Aid, LLCLZB2022-10-28
00814889014153Front LineProstat First Aid, LLCLZB2022-10-28
00814889014160Front LineProstat First Aid, LLCLZB2022-10-28
00814889014207Front LineProstat First Aid, LLCLZB2022-10-28
00814889010193Front LineProstat First Aid, LLCLZB2022-10-27
00814889010209Front LineProstat First Aid, LLCLZB2022-10-27
00814889013798Front LineProstat First Aid, LLCLZB2022-10-27
00073577903777First Aid OnlyAcme United CorporationLZB2022-01-22