The following data is part of a premarket notification filed by Central Medicare Sdn Bhd with the FDA for Powder Free Nitrile Examination Gloves, Nonsterile,(blue,black, And White Colored).
| Device ID | K143247 |
| 510k Number | K143247 |
| Device Name: | Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, And White Colored) |
| Classification | Polymer Patient Examination Glove |
| Applicant | CENTRAL MEDICARE SDN BHD PT 2609-2620, BT 8 JALAN CHANGKAT JONG Teluk Intan, MY 36000 |
| Contact | Th Chong |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-11-12 |
| Decision Date | 2015-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00686864059486 | K143247 | 000 |
| 20686864055055 | K143247 | 000 |
| 20686864053983 | K143247 | 000 |
| 20686864053976 | K143247 | 000 |
| 20686864053969 | K143247 | 000 |
| 20686864053952 | K143247 | 000 |