Disposable Sterilized Latex Surgical Gloves

GUDID 16972267280130

Powder-free textured; The packages of proposed device including immediate package, middle box package and outer carton package. Immediate package quantity: 1 pair Middle box package quantity: 50 pairs Outer carton package quantity: 400 pairs

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

Hevea-latex surgical glove, non-powdered, non-antimicrobial
Primary Device ID16972267280130
NIH Device Record Keyff86b716-d95d-4a31-a3de-116c0c4e7f27
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Sterilized Latex Surgical Gloves
Version Model Number8
Company DUNS421353735
Company NameJiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
Device Count1
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
GS106972267280133 [Primary]
GS116972267280130 [Package]
Contains: 06972267280133
Package: [50 Units]
In Commercial Distribution
GS126972267280137 [Package]
Contains: 06972267280133
Package: [400 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KGOSurgeon'S Gloves

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-26
Device Publish Date2022-07-18

On-Brand Devices [Disposable Sterilized Latex Surgical Gloves]

16972267280000Powder-free textured; The packages of proposed device including immediate package, middle box pa
16972267280147Powder-free textured; The packages of proposed device including immediate package, middle box p
16972267280130Powder-free textured; The packages of proposed device including immediate package, middle box p
16972267280123Powder-free textured; The packages of proposed device including immediate package, middle box p
16972267280116Powder-free textured; The packages of proposed device including immediate package, middle box pa
16972267280109Powder-free textured; The packages of proposed device including immediate package, middle box pa

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