FDA 510(k) Applications for Medical Device:
Gown, Isolation, Surgical
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K982369 | ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD.- K | MCGRAW PARK | IL | 60085 |
| K221027 | Allmed Medical (Hubei) Protective Products Co., Ltd |
No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, | Zhijiang | 443299 | |
| K190306 | AMD Medicom Inc. |
2555 Chemin de l'Aviation | Pointe-Claire, Montreal | H9P 2Z2 | |
| K954747 | AMERASIA CORP. |
4121 TIGRIS WAY | RIVERSIDE | CA | 92503 |
| K970814 | AMERICAN SEAL CO. |
25029 VIKING ST. | HAYWARD | CA | 94545 |
| K211538 | AZAC Group |
17870 Castleton St. Suite 121 | City of Industry | CA | 91748 |
| K003749 | BANTA HEALTHCARE |
PO BOX 4341 | CROFTON | MD | 21114 |
| K160339 | Cardinal Health 200, LLC |
1500 Waukegan Road | Waukegan | IL | 60085 |
| K210785 | Chongqing Litai Fashion Group Limited Company |
Building D7-1, Chongqing China Textile & Garment City | Chongqing | ||
| K230135 | Copioumed International Inc. |
16F-4, No.1, Fuxing N. Rd., Songshan Dist., | Taipei City | 105 | |
| K960999 | COPIOUMED INTL., INC. |
6F-1 NO. 169-12, SEC. 2 | TAIPEI, TAAAAIWAN R.O.C. | ||
| K212422 | Crown Name Disposable Hygiene Products Fty.Ltd. |
Chengbei Industrial Zone,Zhucheng Ave,Xinzhou District | Wuhan | 431400 | |
| K971702 | FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD |
11250 DALE ST. #59 | GARDEN GROVE | CA | 92841 |
| K210148 | Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. |
Beysan Sanayi Sitesi, Dereboyu Caddesi. | Istanbul | 34524 | |
| K212698 | Foshan Nanhai Plus Medical Co Ltd |
Shatou Jiujiang Town, Nanhai District | Foshan | 528208 | |
| K954549 | GLOBAL HEALTHCARE, INC. |
2110 FEDERAL RD. | ROSWELL | GA | 30075 |
| K210131 | GRI-Alleset, Inc |
4142 Industry Way | Flowery Branch | GA | 30542 |
| K213832 | Hubei Xinxin Non-woven Co., Ltd. |
Taizihu Industrial Park, Pengchang Town | Xiantao | 433018 | |
| K214116 | Hubei Xinxin Non-woven Co.,Ltd. |
Taizihu Industrial Park, Pengchang Town | Xiantao | 433018 | |
| K171535 | Jingzhou Haixin Green Cross Medical Products Co., Ltd |
Room 916-918, Floor 9, International Finance Center | Wuhan | 430015 | |
| K212504 | Kenpax International Limited |
Flat 5, 5/F, Wing On Plaza, 62 Mody Road Tsim Sha Tsui, | Hong Kong | 999077 | |
| K972410 | KENTRON HEALTH CARE, INC. |
3604 KELTON JACKSON ROAD | SPRINGFIELD | TN | 37172 |
| K971917 | KENTRON HEALTH CARE, INC. |
3604 KELTON JACKSON ROAD | SPRINGFIELD | TN | 37172 |
| K160471 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K210414 | Medtecs (Taiwan) Corp. |
11F., No. 9, Songgao Road, Xinyi Dist. | Taipei City | 11073 | |
| K223467 | Nanning TECBOD Biological Technology Co.,Ltd. |
Room 601 Fool 6, B2 Building, No. 19 Guokai Dadao, | Naning | 530033 | |
| K212717 | Paneffort, LLC |
| Rochester | NY | 14626 |
| K160361 | PRIMED MEDICAL PRODUCTS INC. |
3RD FLOOR, 1259-91 ST SW. | EDMONTON | T6X1E9 | |
| K212633 | String King Lacrosse, LLC |
19100 S Vermont Ave. | Gardena | CA | 90248 |
| K202310 | Wildcat PPE, LLC |
301 S. Trade Center Pkwy | Conroe | TX | 77385 |
| K220528 | Wuhan Dymex Healthcare Co., Ltd. |
Room 1701, Unit 2, Building 5, Jinsegangwan Phase 5, | Wuhan | 430000 | |
| K212357 | Wuhan Zonsen Medical Products Co., Ltd |
No 8 Jinchao Road, Zhucheng Street, Xinzhou District | Wuhan | 431000 | |
| K223304 | Xiamen Probtain Medical Technology Co., Ltd |
4th Floor, No.1 Building, No.6 Ji'an Road, Tong'an District | Xiamen | 361100 | |
| K223411 | Xiamen Probtain Medical Techology Co., Ltd |
4th Floor, No.1 Building, No.6 Ji'an Road, Tong'an District | Xiamen | 361100 | |
| K203415 | Yanbian Pacific Textile Co., LTD |
Longjing industry concentration area | Longjing city | 133400 |
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