The following data is part of a premarket notification filed by Tangshan Changrong Glove Co., Ltd. with the FDA for Powder-free Vinyl Patient Examination Gloves.
| Device ID | K100339 |
| 510k Number | K100339 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TANGSHAN CHANGRONG GLOVE CO., LTD. JIANXIANG YUAN NO. 209 BEI SI HUAN ZHO Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan TANGSHAN CHANGRONG GLOVE CO., LTD. JIANXIANG YUAN NO. 209 BEI SI HUAN ZHO 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 | 2010-02-05 |
| Decision Date | 2010-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784261416 | K100339 | 000 |
| 00811033010511 | K100339 | 000 |
| 00811033010535 | K100339 | 000 |
| 00811033010559 | K100339 | 000 |
| 00842312128412 | K100339 | 000 |
| 00842312128436 | K100339 | 000 |
| 00842312128450 | K100339 | 000 |
| 00842312128474 | K100339 | 000 |
| 00616784261119 | K100339 | 000 |
| 00616784261218 | K100339 | 000 |
| 00616784261317 | K100339 | 000 |
| 00811033010498 | K100339 | 000 |