|
Device |
medical glove, specialty |
Definition |
A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc. |
Product Code | LZC |
Regulation Number |
880.6250
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Device Class |
1
|
Premarket Reviews |
Manufacturer | Decision |
0 & M HALYARD, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
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ANHUI XINYISHENG MEDICAL TECHNOLOGY CO., LTD |
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SUBSTANTIALLY EQUIVALENT
|
1
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ASPEN GLOVE SDN. BHD. |
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SUBSTANTIALLY EQUIVALENT
|
1
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BETTER CARE PLASTIC TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BRIGHTWAY HOLDINGS SDN BHD |
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SUBSTANTIALLY EQUIVALENT
|
1
|
CAREPLUS (M) SDN BHD |
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SUBSTANTIALLY EQUIVALENT
|
1
|
CENTRAL MEDICARE SDN. BHD. |
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SUBSTANTIALLY EQUIVALENT
|
4
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CHANGZHOU UNIVERSAL MEDICAL EQUIPMENT CO. LTD |
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SUBSTANTIALLY EQUIVALENT
|
1
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COMFORT RUBBER GLOVES INDUSTRIES SDN. BHD. |
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SUBSTANTIALLY EQUIVALENT
|
1
|
ENCOMPASS INDUSTRIES SDN. BHD. |
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SUBSTANTIALLY EQUIVALENT
|
1
|
EVER GLOBAL (VIETNAM) ENTERPRISE CORP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GMP MEDICARE SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GMP MEDICARE SDN BHD (F25) |
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SUBSTANTIALLY EQUIVALENT
|
2
|
GX CORPORATION SDN BHD |
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SUBSTANTIALLY EQUIVALENT
|
1
|
HAINAN ASTHER MEDICAL EQUIPMENT CO., LTD |
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SUBSTANTIALLY EQUIVALENT
|
1
|
HALYARD HEALTH |
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SUBSTANTIALLY EQUIVALENT
|
2
|
HARTALEGA SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HL RUBBER INDUSTRIES SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU NANFANG MEDICAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JR ENGINEERING & MEDICAL TECHNOLOGIES (M) SDN.BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KIMBERLY-CLARK |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LATEXX MANUFACTURING SDN.BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAXTER GLOVE MANUFACTURING SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDLINE INDUSTIRES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NIUJIAN TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NORTHSTAR HEALTHCARE HOLDINGS |
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SUBSTANTIALLY EQUIVALENT
|
1
|
O & M HALYARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PERUSAHAAN GETAH ASAS SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SGMP CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHEN WEI (USA), INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHEN WEI USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHOWA BEST GLOVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WEAR SAFE (MALAYSIA) SDN. BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WRP ASIA PACIFIC SDN. BHD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
YTY INDUSTRY (MANJUNG) SDN BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K182383 Non-Sterile, PF Nitrile Examination Gloves, Tested ...
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