FDA.reportPublic FDA data

Posi-Prene Pink

Primary DI
00850006162505
Brand
Posi-Prene Pink
Company
Clinical Supply Company
Model
P2400PF/S
Device description
Posi-Prene Pink, 6 Gram C.R., Powder Free, Examination Glove, Small Case
Published
2026-03-10
Public version status
New
Distribution status
Not 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
00850006162505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006162505008500061625058500061625050850006162505

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
Handling Environment Temperature50 Degrees Fahrenheit100 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
620679308
Device count
1
DM exempt
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810145952153NeulynxMedgluv Inc.LZA2026-06-26
10304040194048EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194055EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194062EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194079EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194086EssentialsHENRY SCHEIN, INC.LZA2026-06-25
00050428426777CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLZA2026-06-24
00884389961196CURADMEDLINE INDUSTRIES, INC.LZA2026-06-23
00884389961202CURADMEDLINE INDUSTRIES, INC.LZA2026-06-23
00196633795946Kirkland SignatureCostco Wholesale CorporationLZA2026-06-17
00840546402292sunnycareAgio Group Inc.LZA2026-06-10
00840546402315sunnycareAgio Group Inc.LZA2026-06-10
00840546402339sunnycareAgio Group Inc.LZA2026-06-10
00840546402353sunnycareAgio Group Inc.LZA2026-06-10
00840546402377sunnycareAgio Group Inc.LZA2026-06-10
00840546402391sunnycareAgio Group Inc.LZA2026-06-10
00197344133812MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133836MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133850MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133874MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04