FDA.reportPublic FDA data

CORRECT TOUCH

Primary DI
00850009122452
Brand
CORRECT TOUCH
Company
Ct International
Model
SGPF900
Device description
Latex Powder Free Sterile Surgical Gloves, size 9.0 CARTON
Published
2021-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850009122452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850009122452008500091224528500091224520850009122452

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; 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 both the patient and the staff against contamination from microorganisms. 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
Expiration date on label
true
Contains 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

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