The following data is part of a premarket notification filed by Dipped Products (thailand) Limited with the FDA for Palm-pro Chemo-guard Nitrile Powder Free Examination Glove.
| Device ID | K161929 |
| 510k Number | K161929 |
| Device Name: | Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Dipped Products (Thailand) Limited 82/2 MOO 9, Tumbon Rattapum Amphur Khun Nieng, TH 90220 |
| Contact | Nilaksha Pushpakumara |
| Correspondent | Indraj Bamrah Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-14 |
| Decision Date | 2017-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00612479220720 | K161929 | 000 |
| 10850036973086 | K161929 | 000 |
| 10850036973062 | K161929 | 000 |
| 10850036973048 | K161929 | 000 |
| 10850036973024 | K161929 | 000 |
| 10850036973000 | K161929 | 000 |
| 00810054580751 | K161929 | 000 |
| 00810054580737 | K161929 | 000 |
| 00810054580713 | K161929 | 000 |
| 00810054580706 | K161929 | 000 |
| 00612479150256 | K161929 | 000 |
| 00612479150270 | K161929 | 000 |
| 00612479158665 | K161929 | 000 |
| 00612479158603 | K161929 | 000 |
| 00612479158597 | K161929 | 000 |
| 00612479150393 | K161929 | 000 |
| 00612479150379 | K161929 | 000 |
| 00612479150355 | K161929 | 000 |
| 00612479150331 | K161929 | 000 |
| 00612479150317 | K161929 | 000 |
| 00612479150294 | K161929 | 000 |
| 00810054580683 | K161929 | 000 |