FDA.reportPublic FDA data

Reflex

Primary DI
00811114031084
Brand
Reflex
Company
Unisafe Inc.
Model
RF500L
Device description
Powder-Free Vinyl Examination Gloves
Published
2022-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LYZVinyl Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYZVinyl Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811114031121PackageGS110In Commercial Distribution
00811114031084PrimaryGS10
10811114031081Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811114031121008111140311218111140311210811114031121
00811114031084008111140310848111140310840811114031084
1081111403108110811114031081

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 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.

Regulatory Flags#

DUNS number
080171627
Device count
100
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811114031602ProglovePGV500M2026-05-21
00811114031596ProglovePGV500S2026-05-20
00811114031619ProglovePGV500L2026-05-20
00811114031626ProglovePGV500XL2026-05-20
00811114031930MilgloveN5SM2025-04-11
00811114031947MilgloveN5MD2025-04-11
00811114031954MilGloveN5LG2025-04-11
00811114031961MilgloveN5XL2025-04-11
00811114031978MilgloveN5XXL2025-04-11
00811114031985MilgloveN5SM2025-04-11
00811114032029MilgloveN5MD2025-04-11
00811114031992MilGloveN5LG2025-04-11
00811114032005MilgloveN5XL2025-04-11
00811114032012MilgloveN5XXL2025-04-11
00811114030605Black PythonPY700S2023-07-31
00811114030612Black PythonPY700M2023-07-31
00811114030629Black PythonPY700L2023-07-31
00811114030636Black PythonPY700XL2023-07-31
00811114030704CopperheadCH500S2023-07-31
00811114030735CopperheadCH500L2023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850084857218MedClickMedClick LLCLYZ2026-07-22
00850084857225MedClickMedClick LLCLYZ2026-07-22
00850084857232MedClickMedClick LLCLYZ2026-07-22
00850084857249MedClickMedClick LLCLYZ2026-07-22
00850084857256MedClickMedClick LLCLYZ2026-07-22
00850084857263MedClickMedClick LLCLYZ2026-07-22
00850084857270MedClickMedClick LLCLYZ2026-07-22
00850084857287MedClickMedClick LLCLYZ2026-07-22
00850084857294MedClickMedClick LLCLYZ2026-07-22
00850084857300MedClickMedClick LLCLYZ2026-07-22
00850084857317MedClickMedClick LLCLYZ2026-07-22
00850084857324MedClickMedClick LLCLYZ2026-07-22
00080196515939CURADMEDLINE INDUSTRIES, INC.LYZ2026-07-06
00810145952054NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952061NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952078NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952085NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952092NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00713733712835MeijerMEIJER, INC.LYZ2026-06-05
10840330701911ProCureTwin Med, LLCLYZ2026-05-27
10840330701928ProCureTwin Med, LLCLYZ2026-05-27
10840330701935ProCureTwin Med, LLCLYZ2026-05-27
10840330701942ProCureTwin Med, LLCLYZ2026-05-27
10840330701959ProCureTwin Med, LLCLYZ2026-05-27
10840330701966ProCureTwin Med, LLCLYZ2026-05-27
10840330701973ProCureTwin Med, LLCLYZ2026-05-27
10840330701980ProCureTwin Med, LLCLYZ2026-05-27
10840330701997ProCureTwin Med, LLCLYZ2026-05-27
10840330702253ProCureTwin Med, LLCLYZ2026-05-27
10840330702260ProCureTwin Med, LLCLYZ2026-05-27