FDA.reportPublic FDA data

CORRECT TOUCH

Primary DI
00850057303155
Brand
CORRECT TOUCH
Company
Ct International
Model
STN104
Device description
Blue Powder Free Nitrile Exam Gloves, Size X-Large - Carton
Published
2024-01-15
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
FMCPatient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMCPatient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850057303155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057303155008500573031558500573031550850057303155

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
186819520
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
00850009122926CORRECT TOUCHSVGPF022023-05-22
00850009122933CORRECT TOUCHSVGPF032023-05-22
00850009122940CORRECT TOUCHSVGPF042023-05-22
10850009122923CORRECT TOUCHSVGPF022023-05-22
10850009122930CORRECT TOUCHSVGPF032023-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973576425321ruyueShandong Ruyue Medical Technology Co.,LtdFMC2024-06-07
06973576425437ruyueShandong Ruyue Medical Technology Co.,LtdFMC2024-06-07
06973576425215ruyueShandong Ruyue Medical Technology Co.,LtdFMC2024-06-07
06973576425338ruyueShandong Ruyue Medical Technology Co.,LtdFMC2024-06-07
06973576425444ruyueShandong Ruyue Medical Technology Co.,LtdFMC2024-06-07
00850056091152CORRECT TOUCHCt InternationalFMC2024-01-15
00850056091169CORRECT TOUCHCt InternationalFMC2024-01-15
00850056091176CORRECT TOUCHCt InternationalFMC2024-01-15
00850056091183CORRECT TOUCHCt InternationalFMC2024-01-15
00850056091190CORRECT TOUCHCt InternationalFMC2024-01-15
00850056091206CORRECT TOUCHCt InternationalFMC2024-01-15
00850056091213CORRECT TOUCHCt InternationalFMC2024-01-15
00850056091220CORRECT TOUCHCt InternationalFMC2024-01-15
00850057303087CORRECT TOUCHCt InternationalFMC2024-01-15
00850057303094CORRECT TOUCHCt InternationalFMC2024-01-15
00850057303100CORRECT TOUCHCt InternationalFMC2024-01-15
00850057303117CORRECT TOUCHCt InternationalFMC2024-01-15
00850057303124CORRECT TOUCHCt InternationalFMC2024-01-15
00850057303131CORRECT TOUCHCt InternationalFMC2024-01-15
00850057303148CORRECT TOUCHCt InternationalFMC2024-01-15
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00810101520556Firm TouchElite Safety ProductsFMC2022-11-30
00847713000510microdotCambridge Sensors USA LLCFMC2022-11-28