Examination gloves – Type A (Latex gloves)

Primary DI
26972267280328
Brand
Examination gloves – Type A (Latex gloves)
Company
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
Model
M
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
Rx
false
OTC
true
Sterile
false
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
26972267280328PackageGS120In Commercial Distribution
16972267280321PrimaryGS10
06972267280324Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697226728032826972267280328
1697226728032116972267280321
06972267280324069722672803246972267280324

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421353735
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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
16972267280352Examination gloves – Type A (Latex gloves)XL2022-08-10
26972267280311Examination gloves – Type A (Latex gloves)S2022-08-10
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

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10076490456532TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
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