|
|
| Device |
gown, surgical |
| Product Code | FYA |
| Regulation Number |
878.4040
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| 3A MEDICAL PRODUCTS CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| 3M COMPANY CORP |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| A PLUS INTERNATIONAL, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ALLMED MEDICAL (HUBEI) PROTECTIVE PRODUCTS CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| AMMEX-WEIDA (HUBEI) HEALTH AND SAFETY PRODUCTS CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ANHUI MEDPUREST MEDICAL TECHNOLOGY CO.,LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BAM CORP., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BARCO TEKSTIL SANAYI VE TICARET A.S. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BAYTEKS TEKNIK TEKSTIL SAN. VE TIC. A.S. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BOSTON SCIENTIFIC CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CARDINAL HEALTH 200, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CARDINAL HEALTH 200, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
4
|
| CARDINAL HEALTH LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CHANGZHOU HOLYMED PRODUCTS CO LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| COBES INDUSTRIES CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DUKAL CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ELEVATE TEXTILES |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| EXACT MEDICAL MANUFACTURING, INC |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| EXCELLENT MEDICAL TECHNOLOGY GROUP CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| FELIKS PLASTIK LAMINASYON VE AMBALAJ MALZEMELERI |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| FELIKS PLASTIK LAMINASYON VE AMBALAJ MALZEMELERI SANAYI |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| FOSHAN NANHAI PLUS MEDICAL CO LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| FOSHAN NANHAI PLUS MEDICAL CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| FUGOU COUNTY SHENXIANG MANUFACTURING CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| GMAX INDUSTRIES, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| GUANGZHOU FUZELONG HYGIENE MATERIAL CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| HALYARD HEALTH, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| HANGZHOU ATEK MEDICAL & TEXTILE CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| HANGZHOU JINCHENG MEDICAL SUPPLIER MANUFACTURE CO. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| HENAN ROBESTAIN MEDICAL PRODUCTS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| HENAN YADU INDUSTRIAL CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| HUBEI WANLI PROTECTIVE PRODUCTS CO. LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| HUBEI WOOZON HEALTHCARE CO.,LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| JIANGSU GUANGDA MEDICAL MATERIAL, CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| JIANGSU MEDPLUS NON-WOVEN MANUFACTURER CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| KIMBERLY-CLARK CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| KIMBERLY-CLARK CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| LAC MAC, LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MEDCARE SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MEDLINE INDUSTRIES LP |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MEDLINE INDUSTRIES, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
5
|
| MEDLINE INDUSTRIES, LP. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MICROTEK MEDICAL, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| NANNING TECBOD BIOLOGICAL TECHNOLOGY CO.,LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| O&M HALYARD, INC |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| O&M HALYARD, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| OMNIA SPA |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| OPERATING ROOM INNOVATIONS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| PROMEDICAL PRODUCTS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SEJONG HEALTHCARE CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHANDONG KANGLI MEDICAL EQUIPMENT TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SKLAR CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SKYPRO MEDICAL SUPPLIES COMPANY |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SRI SURGICAL |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| STRINGKING |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| STRYKER CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| SUZHOU JANEE MEDICAL TECHNOLOGY CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| UNICOGLOBAL, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| UNIMAX MEDICAL PRODUCTS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| WEIHAI DISHANG MEDICAL TECHNOLOGY CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| WINNER MEDICAL CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| WUHAN DYMEX HEALTHCARE CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
|
1. K211809 Surgical Gown
|
| WUHAN ZONSEN MEDICAL PRODUCTS CO.,LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| WUJIANG TUTAIKE TEXTILES & FINISHING CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| XIAMEN PROBTAIN MEDICAL TECHOLOGY CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| XIANNING MARVELDAS PROTECTIVE ARTICLES CO.,LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| XIANTAO DINGCHENG NON-WOVEN PRODUCT CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| XIANTAO RAYXIN MEDICAL PRODUCTS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| XIANTAO RHYCOM NON-WOVEN PRODUCTS CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| XIANTAO TOPMED NONWOVEN PROTECTIVE PRODUCTS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| XIANTAO ZHIBO NON-WOVEN PRODUCTS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO.,L |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ZIMMER SURGICAL, INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ZIMMER, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
|
|
|
|
