The following data is part of a premarket notification filed by Tangshan Green Healthcare Co., Ltd. with the FDA for Powder-free Vinyl Patient Examination Gloves.
| Device ID | K093277 |
| 510k Number | K093277 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TANGSHAN GREEN HEALTHCARE CO., LTD. RM 1606 .1. JIANXIANG YUAN NO. 209 BEI SI HUAN Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan TANGSHAN GREEN HEALTHCARE CO., LTD. RM 1606 .1. JIANXIANG 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 | 2009-10-19 |
| Decision Date | 2009-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00041415027749 | K093277 | 000 |