FDA.reportPublic FDA data

CORRECT TOUCH

Primary DI
10850009122169
Brand
CORRECT TOUCH
Company
Ct International
Model
SVGPF01
Device description
Synthetic Vinyl Exam Gloves Small Case
Published
2023-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LYZVinyl Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850009122169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085000912216910850009122169

GMDN Terms#

Term, Definition table
TermDefinition
Ethylene vinyl acetate examination/treatment glove, non-powderedA device made of ethylene vinyl acetate (EVA) copolymer 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
186819520
Device count
1
Premarket 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
00850056091152CORRECT TOUCHNPXINBLK1012024-01-15
00850056091169CORRECT TOUCHNPXINBLK1012024-01-15
00850056091176CORRECT TOUCHNPXINBLK1022024-01-15
00850056091183CORRECT TOUCHNPXINBLK1022024-01-15
00850056091190CORRECT TOUCHNPXINBLK1032024-01-15
00850056091206CORRECT TOUCHNPXINBLK1032024-01-15
00850056091213CORRECT TOUCHNPXINBLK1042024-01-15
00850056091220CORRECT TOUCHNPXINBLK1042024-01-15
00850057303087CORRECT TOUCHSTN1012024-01-15
00850057303094CORRECT TOUCHSTN1012024-01-15
00850057303100CORRECT TOUCHSTN1022024-01-15
00850057303117CORRECT TOUCHSTN1022024-01-15
00850057303124CORRECT TOUCHSTN1032024-01-15
00850057303131CORRECT TOUCHSTN1032024-01-15
00850057303148CORRECT TOUCHSTN1042024-01-15
00850057303155CORRECT TOUCHSTN1042024-01-15
00850009122926CORRECT TOUCHSVGPF022023-05-22
00850009122933CORRECT TOUCHSVGPF032023-05-22
00850009122940CORRECT TOUCHSVGPF042023-05-22
10850009122923CORRECT TOUCHSVGPF022023-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00713733712835MeijerMEIJER, INC.LYZ2026-06-05
10840330701911ProCureTwin Med, LLCLYZ2026-05-27
10840330701928ProCureTwin Med, LLCLYZ2026-05-27
10840330701935ProCureTwin Med, LLCLYZ2026-05-27
10840330701942ProCureTwin Med, LLCLYZ2026-05-27
10840330701959ProCureTwin Med, LLCLYZ2026-05-27
10840330701966ProCureTwin Med, LLCLYZ2026-05-27
10840330701973ProCureTwin Med, LLCLYZ2026-05-27
10840330701980ProCureTwin Med, LLCLYZ2026-05-27
10840330701997ProCureTwin Med, LLCLYZ2026-05-27
10840330702253ProCureTwin Med, LLCLYZ2026-05-27
10840330702260ProCureTwin Med, LLCLYZ2026-05-27
10840330702277ProCureTwin Med, LLCLYZ2026-05-27
10840330702284ProCureTwin Med, LLCLYZ2026-05-27
10840330705162ProCureTwin Med, LLCLYZ2026-05-27
10840330705179ProCureTwin Med, LLCLYZ2026-05-27
10840330705186ProCureTwin Med, LLCLYZ2026-05-27
10840330705193ProCureTwin Med, LLCLYZ2026-05-27
10840330705209ProCureTwin Med, LLCLYZ2026-05-27
10840330705216ProCureTwin Med, LLCLYZ2026-05-27
10840330705223ProCureTwin Med, LLCLYZ2026-05-27
10840330705230ProCureTwin Med, LLCLYZ2026-05-27
20193489081562MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
20193489081586MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
20193489081593MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
10889483584446AirLife™AIRLIFELYZ2025-02-14
20197344098184SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-27
20197344098160SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
20197344098177SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
20197344098191SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26