FDA.reportPublic FDA data

Posi-Prene White

Primary DI
00850006162710
Brand
Posi-Prene White
Company
Clinical Supply Company
Model
W2400PF/S
Device description
W2400PF/S, Posi-Prene White, 6 Gram, C.R., Powder Free, Examination Glove, Size Small, 100/Box
Published
2026-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850006162093PackageGS1100In Commercial Distribution
00850006162710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006162093008500061620938500061620930850006162093
00850006162710008500061627108500061627100850006162710

GMDN Terms#

Term, Definition table
TermDefinition
Polychloroprene examination/treatment glove, non-powderedA device made of polychloroprene (neoprene) 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/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit100 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-800-468-0188Clinicalsupply@clinicalsupplycompany.com

Regulatory Flags#

DUNS number
620679308
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850083634117Posi-Prene Edge Green3400PF/XS2026-05-01
00850083634131Posi-Prene Edge Green3400PF/S2026-05-01
00850083634155Posi-Prene Edge Green3400PF/M2026-05-01
00850083634179Posi-Prene Edge Green3400PF/L2026-05-01
00850083634193Posi-Prene Edge Green3400PF/XL2026-05-01
00850083634209Posi-Prene Edge PinkP3400PF/XS2026-05-01
00850083634230Posi-Prene Edge PinkP3400PF/S2026-05-01
00850083634254Posi-Prene Edge PinkP3400PF/M2026-05-01
10850006162120Posi-Prene WhiteW2400PF/XL2026-03-24
10850083634565Posi-Shield5400PF/M2026-03-24
00850006162383Posi-Shield2450PF/M2026-03-24
00850006162390Posi-Shield2450PF/XS2026-03-24
00850006162406Posi-Shield2450PF/L2026-03-24
00850006162413Posi-Shield2450PF/XL2026-03-24
00850006162420Posi-Shield2450PF/XXL2026-03-24
00850006162437Posi-Shield Advanced5450PF/XXL2026-03-24
00850006162444Posi-Shield Advanced5450PF/XL2026-03-24
00850006162451Posi-Shield Advanced5450PF/L2026-03-24
00850006162468Posi-Shield Advanced5450PF/M2026-03-24
00850006162475Posi-Shield Advanced5450PF/S2026-03-24

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Primary DI, Brand, Company table
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00850054870575BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870582BAYLAB USABaylab USA, LLCLZA2026-10-01
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00662956205320Body GuardFastenal CompanyLZA2026-09-30
00662956210171Body GuardFastenal CompanyLZA2026-09-30
10860015093766MaadhoMaadho Distributors Inc.LZA2026-09-24
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10860015093780MaadhoMaadho Distributors Inc.LZA2026-09-24
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00811114033026TopGripUnisafe Inc.LZA2026-08-14
00850016052001NiTouchKasa Trading, LLCLZA2026-08-03
00850016052025NiTouchKasa Trading, LLCLZA2026-08-03
00850016052049NiTouchKasa Trading, LLCLZA2026-08-03
00850016052056NiTouchKasa Trading, LLCLZA2026-08-03