The following data is part of a premarket notification filed by Tangshan Kaiyue Glove Co., Ltd. with the FDA for Nitrile Powder Free Patient Examination Gloves.
| Device ID | K110146 |
| 510k Number | K110146 |
| Device Name: | NITRILE POWDER FREE PATIENT EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | TANGSHAN KAIYUE GLOVE CO., LTD. RM 1606 BLDG 1 JIANXIANG YUAN NO 209, BEI SI HUAN ZHONG RD Haidian District, Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan TANGSHAN KAIYUE GLOVE CO., LTD. RM 1606 BLDG 1 JIANXIANG YUAN NO 209, BEI SI HUAN ZHONG RD Haidian District, Beijing, CN 100083 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-18 |
| Decision Date | 2011-05-13 |
| Summary: | summary |