FDA.reportPublic FDA data

Posi-Shield Advanced

Primary DI
00850006162437
Brand
Posi-Shield Advanced
Company
Clinical Supply Company
Model
5450PF/XXL
Device description
5450PF/XXL, Posi-Shield Advanced, 3.2 Gram, Nitrile, Violet Blue, Powder Free, Examination Glove, Size Double Extra Large, 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
00850006162185PackageGS1100In Commercial Distribution
00850006162437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006162185008500061621858500061621850850006162185
00850006162437008500061624378500061624370850006162437

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile 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 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.

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
00850006162444Posi-Shield Advanced5450PF/XL2026-03-24
00850006162451Posi-Shield Advanced5450PF/L2026-03-24
00850006162468Posi-Shield Advanced5450PF/M2026-03-24
00850006162475Posi-Shield Advanced5450PF/S2026-03-24
00850006162482Posi-Shield Advanced5450PF/XS2026-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
00194346693122EquateWAL-MART STORES, INC.LZA2026-06-02
00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
00768627017282Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017299Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017305Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017312Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
10840330702208ProCureTwin Med, LLCLZA2026-06-01
10840330702215ProCureTwin Med, LLCLZA2026-06-01
10840330702222ProCureTwin Med, LLCLZA2026-06-01
10840330702239ProCureTwin Med, LLCLZA2026-06-01
10840330702246ProCureTwin Med, LLCLZA2026-06-01
10840330706756ProCureTwin Med, LLCLZA2026-06-01
10840330706763ProCureTwin Med, LLCLZA2026-06-01
10840330706770ProCureTwin Med, LLCLZA2026-06-01
10840330706787ProCureTwin Med, LLCLZA2026-06-01