The following data is part of a premarket notification filed by Tangshan Kangyuan Glove Co., Ltd. with the FDA for Powder Free Vinyl Patient Examination Gloves, Colored (yellow).
Device ID | K102569 |
510k Number | K102569 |
Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) |
Classification | Vinyl Patient Examination Glove |
Applicant | TANGSHAN KANGYUAN GLOVE CO., LTD. RM 1606 BLDG. 1. JIANXING YUAN NO. 209 BEI SI HUAN Beijing, CN 100083 |
Contact | Chu Xiaoan |
Correspondent | Chu Xiaoan TANGSHAN KANGYUAN GLOVE CO., LTD. RM 1606 BLDG. 1. JIANXING YUAN NO. 209 BEI SI HUAN 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 | 2010-09-07 |
Decision Date | 2010-10-21 |
Summary: | summary |