|
|
| Device |
vinyl patient examination glove |
| Regulation Description |
Non-powdered patient examination glove. |
| Definition |
A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. |
| Product Code | LYZ |
| Regulation Number |
880.6250
|
|---|
| Device Class |
1
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| ANHUI BYTECH MEDICAL SUPPLIES CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| ANQING PUKANG MEDICAL TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BASIC MEDICAL TECHNOLOGY INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BEST CARE TRADING CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BETTER HEALTH MEDICAL PRODUCTS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BYTECH(DONGTAI) CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CHIFENG HUAWEI MEDICAL SCIENCE&TECHNOLOGY CO.,LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DEZHOU HENGCHANG MEDICAL TECHNOLOGY CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DEZHOU HENGCHANG MEDICAL TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| EVER GLOBAL (VIETNAM) ENTERPRISE CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| GRAND WORK PLASTIC PRODUCTS CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| GUANGDONG KINGFA SCI.& TECH.CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| HEBEI ASTRO MEDICAL SUPPLY CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| INNER MONGOLIA CUREGUARD MEDICAL MATERIALS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| JIANGSU CUREGUARD GLOVE CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| JIANGSU DIHONG INDUSTRY AND TRADE CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| JIANGSU HUAYUAN MEDICAL TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| JIANGXI HANDSPRO PRODUCTS SOLUTIONS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| JIANGXI SHENGDA MEDICAL TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| LIAO NING SHANGWEI MEDICAL PRODUCTS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| LIUPING TRADING CO.,LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| LUTAI MEDICAL TECHNOLOGY CO.,LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MEDLINE INDUSTRIES, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| SHANDONG HONGXIN CHEMICALS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHANDONG JIESHI MEDICAL PRODUCTS CO.,LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHANDONG LANGTAI INTERNATIONAL TRADE CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHANDONG SHANGWEI MEDICAL PRODUCTS CO.,LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHANDONG SHENGSHIXINCHENG MEDICAL SCIENCE & TECHNOLOGY CO., |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHANGHAI SHENGDA MEDICAL APPLICATIONS CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHEN WEI USA INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHIJIAZHUANG HONGJUN PLASTIC MANUFACTURE CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| TAIAN HENGCHANG MEDICAL TECHNOLOGY CO.,LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| TANGSHAN HONGYUN HEALTHCARE PRODUCTS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| TANGSHAN HONGYUN HEALTHCARE PRODUCTS CO.,LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| TOP GLOVE VIETNAM COMPANY LIMITED |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| VIET PHU TRADE AND IMPORT EXPORT CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| XINYING TRADING CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| YUNNAN HUAZHIYUAN MEDICAL TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
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