FDA.reportPublic FDA data

WellBefore

Primary DI
00850046808128
Brand
WellBefore
Company
Social Medical Supply LLC
Model
O7_VINYL-CLEAR_XLARGE
Published
2023-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
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
00850046808128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850046808128008500468081288500468081280850046808128

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
118056777
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850044566006WellBeforeO1_NITRILE_4.0_LARGE2023-05-19
00850044566013WellBeforeO5_NITRILE-BLEND_5.2_SMALL2023-05-19
00850044566020WellBeforeO5_NITRILE-BLEND_5.2_LARGE2023-05-19
00850044566037WellBeforeO1_NITRILE_4.0_SMALL2023-05-19
00850044566044WellBeforeO5_NITRILE-BLEND_5.2_MEDIUM2023-05-19
00850044566082WellBeforeO1_NITRILE_4.0_MEDIUM2023-05-19
00850044566099WellBeforeO5_NITRILE-BLEND_5.2_XLARGE2023-05-19
00850044566112WellBeforeO1_NITRILE_4.0_XLARGE2023-05-19
00850044566921WellBeforeO6_NITRILE-BLACK_4.0_LARGE2023-05-19
00850044566938WellBeforeO6_NITRILE-BLACK_4.0_XLARGE2023-05-19
00850044566945WellBeforeO6_NITRILE-BLACK_4.0_MEDIUM2023-05-19
00850044566952WellBeforeO6_NITRILE-BLACK_4.0_SMALL2023-05-19
00850046808036WellBeforeO6_NITRILE-BLACK_4.0_XSMALL2023-05-19
00850046808043WellBeforeO1_NITRILE_4.0_XSMALL2023-05-19
00850046808098WellBeforeO7_VINYL-CLEAR_SMALL2023-05-19
00850046808104WellBeforeO7_VINYL-CLEAR_MEDIUM2023-05-19
00850046808111WellBeforeO7_VINYL-CLEAR_LARGE2023-05-19
00850046808135WellBeforeO8_VINYL-BLUE_SMALL2023-05-19
00850046808142WellBeforeO8_VINYL-BLUE_MEDIUM2023-05-19
00850046808159WellBeforeO8_VINYL-BLUE_LARGE2023-05-19

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