The following data is part of a premarket notification filed by Rongyao Plastic Produce Co., Ltd with the FDA for Powder Free Vinyl Patient Examination Gloves, Colored (yellow).
| Device ID | K110016 |
| 510k Number | K110016 |
| Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | RONGYAO PLASTIC PRODUCE CO., LTD #58 BINHU ROAD Hengshuicity, CN 053000 |
| Contact | Zhao Gang |
| Correspondent | Zhao Gang RONGYAO PLASTIC PRODUCE CO., LTD #58 BINHU ROAD Hengshuicity, CN 053000 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-03 |
| Decision Date | 2011-08-23 |
| Summary: | summary |