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 |