The following data is part of a premarket notification filed by Tangshan Transocean Plastic Products Co.,ltd. with the FDA for Vinyl Examination Gloves, Powdered.
| Device ID | K033308 |
| 510k Number | K033308 |
| Device Name: | VINYL EXAMINATION GLOVES, POWDERED |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TANGSHAN TRANSOCEAN PLASTIC PRODUCTS CO.,LTD. NO. 188 BENHU ROAD LUANNAN COUNTY Tangshan City; Hebei, CN 063500 |
| Contact | Iris Yang |
| Correspondent | Iris Yang TANGSHAN TRANSOCEAN PLASTIC PRODUCTS CO.,LTD. NO. 188 BENHU ROAD LUANNAN COUNTY Tangshan City; Hebei, CN 063500 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-14 |
| Decision Date | 2003-12-22 |