FDA.reportPublic FDA data

Aloe-Shield

Primary DI
00850006162802
Brand
Aloe-Shield
Company
Clinical Supply Company
Model
6450AF/L
Device description
6450AF/L, 3.5 Gram, Nitrile, Contains Pure Aloe Extract, Green, Powder Free, Examination Glove, Size Large, 200/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
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850006162758PackageGS1200In Commercial Distribution
00850006162802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006162758008500061627588500061627580850006162758
00850006162802008500061628028500061628020850006162802

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
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
20680651500674HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZC2026-06-04
09001570557278Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557308Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557339Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557360Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557391Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557421Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557452Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557483Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557797Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557827Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557858Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557889Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557919Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557940Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557971Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570558008Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557285Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557346Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557377Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12