The following data is part of a premarket notification filed by Shijiazhuang Richful Plastic Co., Ltd. with the FDA for Richful Powder-free Vinyl Patient Examination Gloves, Clear (non-colored).
Device ID | K141305 |
510k Number | K141305 |
Device Name: | RICHFUL POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
Classification | Vinyl Patient Examination Glove |
Applicant | SHIJIAZHUANG RICHFUL PLASTIC CO., LTD. ROOM 1606 BLDG 1 JIANXIANG YUAN NO. 209 BEI SI HUAN ZHONG ROAD, HAIDIAN DIS Beijing, CN 100083 |
Contact | Chu Xiaoan |
Correspondent | Chu Xiaoan SHIJIAZHUANG RICHFUL PLASTIC CO., LTD. ROOM 1606 BLDG 1 JIANXIANG YUAN NO. 209 BEI SI HUAN ZHONG ROAD, HAIDIAN DIS Beijing, CN 100083 |
Product Code | LYZ |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-05-19 |
Decision Date | 2014-08-27 |
Summary: | summary |