The following data is part of a premarket notification filed by Jiangsu Everyguard Plastic Products Co., Ltd with the FDA for Powdered Vinyl Patient Examination Gloves, Clear (non-colored).
| Device ID | K060909 |
| 510k Number | K060909 |
| Device Name: | POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | JIANGSU EVERYGUARD PLASTIC PRODUCTS CO., LTD RM 1606 BLDG 1JIANZIANG YUAN NO 209 BEI SI HUAN SHONG RD HA Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan JIANGSU EVERYGUARD PLASTIC PRODUCTS CO., LTD RM 1606 BLDG 1JIANZIANG YUAN NO 209 BEI SI HUAN SHONG RD HA 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 | 2006-04-03 |
| Decision Date | 2006-05-24 |
| Summary: | summary |