|
Device |
surgeon's gloves |
Definition |
A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. |
Product Code | KGO |
Regulation Number |
878.4460
|
Device Class |
1
|
Premarket Reviews |
Manufacturer | Decision |
AMAZING RUBBER PRODUCTS PVT LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANHUI ANYU LATEX PRODUCTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANSELL HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANSELL HEALTHCARE PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ANSELL HEALTHCARE PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANSELL HEALTHCARE PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ANSELL HEALTHCARE PRODUCTS, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ASPEN GLOVE SDN. BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEST PUTRA GLOVES SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BETA HEALTHCARE PRODUCTS PVT.LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BETTER CARE PLASTIC TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BETTER CARE PLASTIC TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDINAL HEALTH 200, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDINAL HEALTH 200, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDINAL HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
12
|
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CAREGLOVE GLOBAL SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAREPLUS (M) SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ECO MEDI GLOVE SDN. BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELIMEDICAL DEVICES (FUJIAN) INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMERSON & CO. S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMERSON & CO. SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FITONE LATEX PRODUCTS CO., LTD. GUANGDONG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRAND WORK PLASTIC PRODUCTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRAND WORK PLASTIC PRODUCTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUILIN HBM HEALTH PROTECTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GX CORPORATION SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HARTALEGA NGC SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HARTALEGA NGC SDN. BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HARTALEGA SDB. BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HARTALEGA SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HARTALEGA SDN. BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HUTCHINSON SANTE S.N.C. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INEO TECH SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGXI KEMEI MEDICAL APPARATUS & INSTRUMENTS GROUP CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JR ENGINEERING & MEDICAL TECHNOLOGIES (M) SDN. BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JR ENGINEERING & MEDICAL TECHNOLOGIES (M) SDN.BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LDI CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LENORA GLOVE PVT LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LUCENXIA PRESCIENCE AG |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
MEDLINE INDUSTRIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
MODERN HEALTHCARE CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MOLNLYCKE HEALTH CARE US LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MOLNLYCKE HEALTH CARE US, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MOLNLYCKE HEALTH CARE USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MOLNLYCKE HEALTH CARE, US LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MOLNLYCKE HEALTHCARE, US LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MRK HEALTHCARE PVT LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEW ERA MEDICARE SDN. BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PENTAVEST HOLDINGS SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRIMUS GLOVES PVT LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PT MEDISAFE TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PT. MEDISAFE TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PURNA BINA SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PUYANG LINSHI MEDICAL SUPPLIES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SANREA HEALTHCARE PRODUCTS PVT LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEMPERIT INVESTMENTS ASIA PTE. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEMPERIT TECHNISCHE PRODUKTE GESELLCHAFT M.B.H. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SENTIENX SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI JINXIANG LATEX PRODUCTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI MOTEX HEALTHCARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHEN WEI (USA), INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMART GLOVE CORPORATION SDN.BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMART GLOVE CORPORATION SDN.BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ST.MARYS RUBBERS PVT. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU COLOUR-WAY NEW MATERIAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERANG NUSA SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
TERANG NUSA SND BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TG MEDICAL SDN. BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THE EGYPTIAN COMPANY FOR MEDICAL & ELECTRONIC INDUSTRIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOP GLOVE SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WEAR SAFE (MALAYSIA) SDN. BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WRP ASIA PACIFIC SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WRP ASIA PACIFIC SDN. BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
|
|
|
|