Examination gloves – Type A (Latex gloves)

GUDID 26972267280335

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

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID26972267280335
NIH Device Record Keya05d63e1-dc6c-4774-a2a1-314ff7a0393d
Commercial Distribution StatusIn Commercial Distribution
Brand NameExamination gloves – Type A (Latex gloves)
Version Model NumberL
Company DUNS421353735
Company NameJiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106972267280331 [Unit of Use]
GS116972267280338 [Primary]
GS126972267280335 [Package]
Contains: 16972267280338
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYYLatex Patient Examination Glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-18
Device Publish Date2022-08-10

On-Brand Devices [Examination gloves – Type A (Latex gloves)]

26972267280359Powder-free textured; The packages of proposed device including middle box package and outer car
26972267280335Powder-free textured; The packages of proposed device including middle box package and outer ca
26972267280328Powder-free textured; The packages of proposed device including middle box package and outer ca
26972267280311Powder-free textured; The packages of proposed device including middle box package and outer ca

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