The following data is part of a premarket notification filed by Pinnacle Co., Ltd. with the FDA for Synthetic Vinyl Examination Glove Powder Free (yellow/white).
| Device ID | K072228 |
| 510k Number | K072228 |
| Device Name: | SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) |
| 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 | 2008-02-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10653195009982 | K072228 | 000 |
| 10653195009968 | K072228 | 000 |
| 10653195009951 | K072228 | 000 |
| 10653195009920 | K072228 | 000 |
| 10653195009906 | K072228 | 000 |