FDA.reportPublic FDA data

Dental Mates

Primary DI
00860009046412
Brand
Dental Mates
Company
M.Y.T. USA Corp.
Model
Size Small
Published
2022-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K152720000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152720000Xingda Nitrile Powder Free Patient Examination Gloves, Blue ColorXingda Medical Products Co., Ltd.2016-03-10LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009046412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009046412008600090464128600090464120860009046412

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
High-level Disinfectant

Regulatory Flags#

DUNS number
118764392
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00080169153595BORDOVAVINYL EXAM GLOVES SIZE LARGE2022-11-30
00840169153793Dental Mates"Sterilization Pouches 7 1/2 X 14"""2023-02-25
00840169153588BORDOVAVINYL EXAM GLOVES SIZE MEDIUM2022-11-30
00840169153601PLATINUMVINYL EXAM GLOVES SIZE MEDIUM2022-11-30
00840169153618PLATINUMVINYL EXAM GLOVES SIZE LARGE2022-11-30
00860009046467Dental MatesSterilization Pouches 2 1/4 x 52022-11-17
00860009046474Dental MatesSterilization Pouches 3 1/2 x 6 1/22022-11-17
00860009046481Dental MatesSterilization Pouches 3 1/2 x 102022-11-17
00840169153540Dental MatesLATEX EXAM GLOVES SIZE SMALL2022-11-16
00840169153557Dental MatesLATEX EXAM GLOVES SIZE MEDIUM2022-11-16
00840169153564Dental MatesLATEX EXAM GLOVES SIZE LARGE2022-11-16
00840169153571Dental MatesLATEX EXAM GLOVES SIZE XL2022-11-16
00840169153533Dental MatesLATEX EXAM GLOVES XS2022-11-14
00860009046405Dental MatesSize XS2022-08-17
00860009046429Dental MatesSize Medium2022-08-17
00860009046436Dental MatesSize Large2022-08-17
00860009046443Dental MatesSize XL2022-08-17
00860009046450Dental MatesASTM LEVEL 3 MASK2022-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973576425321ruyueShandong Ruyue Medical Technology Co.,LtdFMC2024-06-07
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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
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