The following data is part of a premarket notification filed by Tangshan Zhonghong Pulin Group Co., Ltd. with the FDA for Powder Free Blue Patient Nitrile Examination Glove.
| Device ID | K082598 |
| 510k Number | K082598 |
| Device Name: | POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE |
| Classification | Polymer Patient Examination Glove |
| Applicant | TANGSHAN ZHONGHONG PULIN GROUP CO., LTD. ROOM 1606 BLDG 1, JIANXIANG YUAN NO. 209 BEI SI HUAN ZHO Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan TANGSHAN ZHONGHONG PULIN GROUP CO., LTD. ROOM 1606 BLDG 1, JIANXIANG YUAN NO. 209 BEI SI HUAN ZHO 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 | 2008-09-08 |
| Decision Date | 2009-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970405800045 | K082598 | 000 |