The following data is part of a premarket notification filed by Tangshan Luxiong Plastic Products Co., Ltd. with the FDA for Powdered Vinyl Patient Examination Gloves, Clear (non-colored).
| Device ID | K061659 |
| 510k Number | K061659 |
| Device Name: | POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD. NO. 209 BEI SI HUAN ZHONG ROAD HAIDIAN DISTRICT Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD. NO. 209 BEI SI HUAN ZHONG ROAD HAIDIAN DISTRICT 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 | 2006-06-12 |
| Decision Date | 2006-09-15 |
| Summary: | summary |