|
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
|
ANSELL HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANSELL HEALTHCARE PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANSELL HEALTHCARE PRODUCTS, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ASPEN GLOVE SDN. BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDINAL HEALTH 200, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAREGLOVE GLOBAL SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAREPLUS (M) SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ECO MEDI GLOVE SDN. BHD |
|
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 SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HARTALEGA SDN. BHD. |
|
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
|
MEDLINE INDUSTRIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K192820 SensiCare Neoprene Synthetic Polychloroprene Surgi ...
|
2. K192988 Dermasure Green Sterile SyntheticPolychloroprene P ...
|
3. K193217 SensiCare PI and SensiCare PI Micro Surgical Glove ...
|
4. K201829 SensiCare PI Evolution Surgical Glove (Tested for ...
|
5. K202449 Signature Latex LT, Powder-Free, Surgical Glove, T ...
|
6. K202668 Signature Latex and Signature Latex Micro, Powder- ...
|
7. K203538 SensiCare PI Ortho LT Surgical Glove (Tested for U ...
|
MEDLINE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
1. K192820 SensiCare Neoprene Synthetic Polychloroprene Surgi ...
|
2. K192988 Dermasure Green Sterile SyntheticPolychloroprene P ...
|
3. K193217 SensiCare PI and SensiCare PI Micro Surgical Glove ...
|
4. K201829 SensiCare PI Evolution Surgical Glove (Tested for ...
|
5. K202449 Signature Latex LT, Powder-Free, Surgical Glove, T ...
|
6. K202668 Signature Latex and Signature Latex Micro, Powder- ...
|
7. K203538 SensiCare PI Ortho LT Surgical Glove (Tested for U ...
|
MODERN HEALTHCARE CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MOLNLYCKE HEALTH CARE US LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MOLNLYCKE HEALTH CARE, US LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MRK HEALTHCARE PVT LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEW ERA MEDICARE SDN. BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PENTAVEST HOLDINGS SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PT. MEDISAFE TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PUYANG LINSHI MEDICAL SUPPLIES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEMPERIT TECHNISCHE PRODUKTE GESELLCHAFT M.B.H. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SENTIENX SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMART GLOVE CORPORATION SDN.BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU COLOUR-WAY NEW MATERIAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THE EGYPTIAN COMPANY FOR MEDICAL & ELECTRONIC INDUSTRIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WRP ASIA PACIFIC SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WRP ASIA PACIFIC SDN. BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
|
|
|
|