The following data is part of a premarket notification filed by Dong Tai City Huayi Gloves Co., Ltd. with the FDA for Proprietary / Dongtai/ Other Clients Private Labeling.
| Device ID | K131823 |
| 510k Number | K131823 |
| Device Name: | PROPRIETARY / DONGTAI/ OTHER CLIENTS PRIVATE LABELING |
| Classification | Polymer Patient Examination Glove |
| Applicant | DONG TAI CITY HUAYI GLOVES CO., LTD. RM 1606 BLDG, 1 JIAN XIANG YUAN NO. 209 BEI SI HUAN ZHONG RD HAI DI Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan DONG TAI CITY HUAYI GLOVES CO., LTD. RM 1606 BLDG, 1 JIAN XIANG YUAN NO. 209 BEI SI HUAN ZHONG RD HAI DI 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 | 2013-06-20 |
| Decision Date | 2013-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973082130344 | K131823 | 000 |
| 06973082130115 | K131823 | 000 |
| 06973082130122 | K131823 | 000 |
| 06973082130139 | K131823 | 000 |
| 06973082130146 | K131823 | 000 |
| 06973082130306 | K131823 | 000 |
| 06973082130313 | K131823 | 000 |
| 06973082130320 | K131823 | 000 |
| 06973082130337 | K131823 | 000 |
| 06973082130443 | K131823 | 000 |
| 06973082130450 | K131823 | 000 |
| 06973082130108 | K131823 | 000 |