|
|
| Device |
gown, isolation, surgical |
| Regulation Description |
Surgical apparel. |
| Product Code | FYC |
| Regulation Number |
878.4040
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| ALLMED MEDICAL (HUBEI) PROTECTIVE PRODUCTS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| AZAC GROUP |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CHONGQING LITAI FASHION GROUP LIMITED COMPANY |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| COPIOUMED INTERNATIONAL, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CROWN NAME DISPOSABLE HYGIENE PRODUCTS FTY., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| FLOMAK TEKSTIL MAKINE MUH. MUM. TAAH. SAN. TIC. LTD. STI. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| FOSHAN NANHAI PLUS MEDICAL CO, LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| GRI-ALLESET, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| HUBEI XINXIN NON-WOVEN CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| KENPAX INTERNATIONAL LIMITED |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MEDTECS (TAIWAN) CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| NANNING TECBOD BIOLOGICAL TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| OWENS & MINOR (O&M) HALYARD, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| PANEFFORT, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| STRING KING LACROSSE, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| WILDCAT PPE, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| WUHAN DYMEX HEALTHCARE CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| XIAMEN PROBTAIN MEDICAL TECHOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| YANBIAN PACIFIC TEXTILE CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|
