FDA.reportPublic FDA data

Firm Touch

Primary DI
00810101520495
Brand
Firm Touch
Company
Elite Safety Products
Model
6040BMD (2XL)
Published
2022-07-31
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110981000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810101520495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810101520495008101015204958101015204950810101520495

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
082745034
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810007198699Firm Touch6550MD (M)2022-11-30
00810007198705Firm Touch6550MD (L)2022-11-30
00810007198712Firm Touch6550MD (XL)2022-11-30
00810007198835Firm Touch6550MD (S)2022-11-30
00810101520518Firm Touch6540MD/S2022-11-30
00810101520525Firm Touch6540MD/M2022-11-30
00810101520532Firm Touch6540MD/L2022-11-30
00810101520549Firm Touch6540MD/XL2022-11-30
00810101520556Firm Touch6540MD/2XL2022-11-30
00810007198668Firm Touch6040BMD (M)2022-07-31
00810007198675Firm Touch6040BMD (L)2022-07-31
00810007198682Firm Touch6040BMD (XL)2022-07-31
00810007198828Firm Touch6040BMD (S)2022-07-31
00810007199856ALPHAIS-6040MD (S)2022-07-31
00810007199863ALPHAIS-6040MD (M)2022-07-31
00810007199870ALPHAIS-6040MD (L)2022-07-31
00810007199887ALPHAIS-6040MD (XL)2022-07-31
00810007199894ALPHAIS-6040MD (2XL)2022-07-31
00810101520075Cap'n K09-MWSPN-S2022-07-31
00810101520082Cap'n K09-MWSPN-M2022-07-31

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
00850057303155CORRECT TOUCHCt InternationalFMC2024-01-15
00810007198699Firm TouchElite Safety ProductsFMC2022-11-30
00810007198705Firm TouchElite Safety ProductsFMC2022-11-30
00810007198712Firm TouchElite Safety ProductsFMC2022-11-30
00810007198835Firm TouchElite Safety ProductsFMC2022-11-30
00810101520518Firm TouchElite Safety ProductsFMC2022-11-30
00810101520525Firm TouchElite Safety ProductsFMC2022-11-30
00810101520532Firm TouchElite Safety ProductsFMC2022-11-30
00810101520549Firm TouchElite Safety ProductsFMC2022-11-30
00810101520556Firm TouchElite Safety ProductsFMC2022-11-30