The following data is part of a premarket notification filed by Pinnacle Co., Ltd. with the FDA for Vinyl Examination Glove, Powdered.
| Device ID | K072223 |
| 510k Number | K072223 |
| Device Name: | VINYL EXAMINATION GLOVE, POWDERED |
| Classification | Vinyl Patient Examination Glove |
| Applicant | PINNACLE CO., LTD. 240 RENMIN ROAD LINZI Shandong, CN |
| Contact | David Ding |
| Correspondent | David Ding PINNACLE CO., LTD. 240 RENMIN ROAD LINZI Shandong, CN |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-10 |
| Decision Date | 2008-02-21 |