The following data is part of a premarket notification filed by Iconic Medicare Sdn Bhd with the FDA for Iconic Latex Glove.
| Device ID | K221648 |
| 510k Number | K221648 |
| Device Name: | Iconic Latex Glove |
| Classification | Latex Patient Examination Glove |
| Applicant | Iconic Medicare Sdn Bhd PMT 798, Lingkaran Cassia Selatan, Taman Perindustrian, Bandar Cassia Batu Kawan, MY 14110 |
| 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-07 |
| Decision Date | 2022-08-25 |