The following data is part of a premarket notification filed by Zhangjiangang All Fine Rubber-plastic Products Co. with the FDA for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored).
| Device ID | K092109 |
| 510k Number | K092109 |
| Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ZHANGJIANGANG ALL FINE RUBBER-PLASTIC PRODUCTS CO. RM 1606, BLDG 1, JIAN XIANG YUAN NO.209 BEI SIHUAN ZONG RD 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 | 2009-07-14 |
| Decision Date | 2009-10-09 |
| Summary: | summary |