The following data is part of a premarket notification filed by Srirungruang Global Co., Ltd. with the FDA for Shark Gloves Blue Nitrile Examination Gloves Powder Free, Inconglove Blue Nitrile Examination Gloves Powder Free.
| Device ID | K212308 |
| 510k Number | K212308 |
| Device Name: | SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free |
| Classification | Polymer Patient Examination Glove |
| Applicant | Srirungruang Global Co., LTD. 51/7 Moo1, Mabphai Banbung, TH 20170 |
| Contact | Suttichai Sripradub |
| Correspondent | Aristotle Nafpliotis mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-23 |
| Decision Date | 2021-10-29 |