The following data is part of a premarket notification filed by Tangshan Hongyun Plastic Products Co., Ltd with the FDA for Powdered Vinyl Patient Examination Gloves, Clear (non-colored).
| Device ID | K071999 |
| 510k Number | K071999 |
| Device Name: | POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD ROOM 1606 BLDG. 1, JIANZIANG YUAN NO 209 BEI SI Huan Zhong, Roa; Beijing, CN 10008 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD ROOM 1606 BLDG. 1, JIANZIANG YUAN NO 209 BEI SI Huan Zhong, Roa; Beijing, CN 10008 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-23 |
| Decision Date | 2008-05-08 |
| Summary: | summary |