The following data is part of a premarket notification filed by Iconic Medicare Sdn Bhd with the FDA for Iconic Nitrile Glove.
| Device ID | K212182 |
| 510k Number | K212182 |
| Device Name: | Iconic Nitrile Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Iconic Medicare Sdn Bhd 1-2 Jalan Icon City, 14000 Bukit Mertaj Kuala Lumpur, MY 14000 |
| Contact | Tan Cho Chia |
| Correspondent | A.c. Thirumaran Integrated Assessment Services Pvt Ltd 1495, Manasarovar, 16th Main Road, Anna Nagar West Chennai, IN 600040 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-13 |
| Decision Date | 2021-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D79010684053 | K212182 | 000 |
| D79010684043 | K212182 | 000 |
| D79010684033 | K212182 | 000 |
| D79010684023 | K212182 | 000 |
| D79010684013 | K212182 | 000 |