The following data is part of a premarket notification filed by Mercator Medical (thailand) Ltd. with the FDA for Mcare Powder-free Blue Nitrile Examination Gloves.
| Device ID | K172930 |
| 510k Number | K172930 |
| Device Name: | MCare Powder-free Blue Nitrile Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Mercator Medical (Thailand) LTD. 88/2 Moo 12 Tambon Kampaengphet Amphur Rattaphum, TH |
| Contact | Dariusz Jan Krezymon |
| Correspondent | Dariusz Jan Krezymon Mercator Medical (Thailand) LTD. 88/2 Moo 12 Tambon Kampaengphet Amphur Rattaphum, TH |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-25 |
| Decision Date | 2018-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18859185201363 | K172930 | 000 |
| 18859185201301 | K172930 | 000 |
| 18859185201295 | K172930 | 000 |
| 18859185201288 | K172930 | 000 |
| 18859185201271 | K172930 | 000 |
| 08859185201311 | K172930 | 000 |
| 08859185201304 | K172930 | 000 |
| 08859185201298 | K172930 | 000 |
| 08859185201281 | K172930 | 000 |
| 18859185201318 | K172930 | 000 |
| 08859185201328 | K172930 | 000 |
| 18859185201356 | K172930 | 000 |
| 18859185201349 | K172930 | 000 |
| 18859185201332 | K172930 | 000 |
| 18859185201325 | K172930 | 000 |
| 08859185201366 | K172930 | 000 |
| 08859185201359 | K172930 | 000 |
| 08859185201342 | K172930 | 000 |
| 08859185201335 | K172930 | 000 |
| 08859185201274 | K172930 | 000 |