FDA.reportPublic FDA data

WellBefore

Primary DI
00850046808043
Brand
WellBefore
Company
Social Medical Supply LLC
Model
O1_NITRILE_4.0_XSMALL
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
LZAPolymer Patient Examination Glove

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152720000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152720000Xingda Nitrile Powder Free Patient Examination Gloves, Blue ColorXingda Medical Products Co., Ltd.2016-03-10LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850046808043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850046808043008500468080438500468080430850046808043

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
00850046808098WellBeforeO7_VINYL-CLEAR_SMALL2023-05-19
00850046808104WellBeforeO7_VINYL-CLEAR_MEDIUM2023-05-19
00850046808111WellBeforeO7_VINYL-CLEAR_LARGE2023-05-19
00850046808128WellBeforeO7_VINYL-CLEAR_XLARGE2023-05-19
00850046808135WellBeforeO8_VINYL-BLUE_SMALL2023-05-19
00850046808142WellBeforeO8_VINYL-BLUE_MEDIUM2023-05-19
00850046808159WellBeforeO8_VINYL-BLUE_LARGE2023-05-19

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Primary DI, Brand, Company table
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10840064641262Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
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