FDA.reportPublic FDA data

Examination gloves – Type A (Latex gloves)

Primary DI
16972267280352
Brand
Examination gloves – Type A (Latex gloves)
Company
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
Model
XL
Device description
Powder-free textured; The packages of proposed device including middle box package and outer carton package. Middle box package quantity: 100PCS Outer carton package quantity: 2000PCS
Published
2022-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LYYLatex Patient Examination Glove

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K214017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K214017000Examination gloves-Type A(Latex gloves)Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.2022-07-14LYY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26972267280359PackageGS120In Commercial Distribution
16972267280352PrimaryGS10
06972267280355Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697226728035926972267280359
1697226728035216972267280352
06972267280355069722672803556972267280355

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment 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 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 both the patient and the staff against various contamination. 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.

Regulatory Flags#

DUNS number
421353735
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16972267280314Examination gloves – Type A (Latex gloves)S2022-08-10
16972267280321Examination gloves – Type A (Latex gloves)M2022-08-10
16972267280338Examination gloves – Type A (Latex gloves)L2022-08-10
26972267280311Examination gloves – Type A (Latex gloves)S2022-08-10
26972267280328Examination gloves – Type A (Latex gloves)M2022-08-10
26972267280335Examination gloves – Type A (Latex gloves)L2022-08-10
26972267280359Examination gloves – Type A (Latex gloves)XL2022-08-10
16972267280154Examination gloves – Type C (Nitrile gloves)S2022-07-25
16972267280161Examination gloves – Type C (Nitrile gloves)M2022-07-25
16972267280178Examination gloves – Type C (Nitrile gloves)L2022-07-25
16972267280185Examination gloves – Type C (Nitrile gloves)XL2022-07-25
26972267280151Examination gloves – Type C (Nitrile gloves)S2022-07-25
26972267280168Examination gloves – Type C (Nitrile gloves)M2022-07-25
26972267280175Examination gloves – Type C (Nitrile gloves)L2022-07-25
26972267280182Examination gloves – Type C (Nitrile gloves)XL2022-07-25
06972267280003Disposable Sterilized Latex Surgical Gloves62022-07-18
06972267280102Disposable Sterilized Latex Surgical Gloves6.52022-07-18
06972267280119Disposable Sterilized Latex Surgical Gloves72022-07-18
06972267280126Disposable Sterilized Latex Surgical Gloves7.52022-07-18
06972267280133Disposable Sterilized Latex Surgical Gloves82022-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00021130794461Signature CareBETTER LIVING BRANDS LLCLYY2026-07-16
10850015055871TOUGHGRIP 7 MIL LATEX GLOVES-LULINE, INC.LYY2026-07-14
10850015055888TOUGHGRIP 7 MIL LATEX GLOVES-MULINE, INC.LYY2026-07-14
10850015055895TOUGHGRIP 7 MIL LATEX GLOVES-SULINE, INC.LYY2026-07-14
10850015055901TOUGHGRIP 7 MIL LATEX GLOVES-XULINE, INC.LYY2026-07-14
10850015055918EXT CUFF 12 MIL LATEX GLOVES-LULINE, INC.LYY2026-07-10
10850015055925EXT CUFF 12 MIL LATEX GLOVES-MULINE, INC.LYY2026-07-10
10850015055932EXT CUFF 12 MIL LATEX GLOVES-SULINE, INC.LYY2026-07-10
10850015055949EXT CUFF 12 MIL LATEX GLOVES-XULINE, INC.LYY2026-07-10
10076490456525TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10076490456532TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10076490456549TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10076490456556TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10810141931715VIVIT SupplyVivit Supply LLCLYY2024-05-17
10810141931722VIVIT SupplyVivit Supply LLCLYY2024-05-17
10810141931746VIVIT SupplyVivit Supply LLCLYY2024-05-17
10810141931739VIVIT SupplyVivit Supply LLCLYY2024-05-17
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09555002101060AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101077AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101084AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101091AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101404AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101411AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101428AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101435AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101442AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101558AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101565AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101572AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08