The following data is part of a premarket notification filed by Kaixing Plastic Products Co., Litd. with the FDA for Powder Free Vinyl Patient Examination Glove, Colored (yellow).
| Device ID | K160675 |
| 510k Number | K160675 |
| Device Name: | Powder Free Vinyl Patient Examination Glove, Colored (yellow) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | KAIXING PLASTIC PRODUCTS CO., LITD. 1101 TANGGANG RD LUANNAN COUNTY Tangshan, CN |
| Contact | Dan Ny |
| Correspondent | Daniel Qiu LICHEN COMMERCIAL INFORMATION CONSULTING CO.,LTD ROOM 1304, BUILDING 8, YUNTAI RD. 453 PUDONG NEW DISTRICT, Shanghai, CN 200126 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-10 |
| Decision Date | 2016-08-02 |
| Summary: | summary |