The following data is part of a premarket notification filed by Pinnacle Co., Ltd. with the FDA for Vinyl Examination Glove Powder Free.
| Device ID | K072227 |
| 510k Number | K072227 |
| Device Name: | VINYL EXAMINATION GLOVE POWDER FREE |
| 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 | 2008-02-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10075289132152 | K072227 | 000 |
| 10781311650722 | K072227 | 000 |
| 10781311650623 | K072227 | 000 |
| 00850043630883 | K072227 | 000 |
| 00850043630890 | K072227 | 000 |
| 00850043630906 | K072227 | 000 |
| 00850043630913 | K072227 | 000 |
| 90834515001558 | K072227 | 000 |
| 90834515001541 | K072227 | 000 |
| 90834515001534 | K072227 | 000 |
| 90834515001527 | K072227 | 000 |
| 90834515000353 | K072227 | 000 |
| 90834515000346 | K072227 | 000 |
| 90834515000339 | K072227 | 000 |
| 10781311650821 | K072227 | 000 |
| 10781311650920 | K072227 | 000 |
| 10075289132145 | K072227 | 000 |
| 10075289132138 | K072227 | 000 |
| 10075289132121 | K072227 | 000 |
| 10653195002389 | K072227 | 000 |
| 10653195002365 | K072227 | 000 |
| 10653195002358 | K072227 | 000 |
| 10653195002327 | K072227 | 000 |
| 10653195002303 | K072227 | 000 |
| 10813417020601 | K072227 | 000 |
| 10813417020595 | K072227 | 000 |
| 10813417020588 | K072227 | 000 |
| 10813417020571 | K072227 | 000 |
| 10813417020564 | K072227 | 000 |
| 90834515000322 | K072227 | 000 |