The following data is part of a premarket notification filed by Suretex Limited with the FDA for Microthin Natural Rubber Latex Condom.
| Device ID | K213921 |
| 510k Number | K213921 |
| Device Name: | Microthin Natural Rubber Latex Condom |
| Classification | Condom |
| Applicant | Suretex Limited 31/1 Moo 4, Suratthani-Thakuapha Road Tambon Khao Hua Kwai, Amphur Phunphin, TH 84130 |
| Contact | Kc Nguyen |
| Correspondent | Carole C. Carey C3-Carey Consultants, LLC 9451 Ellsworth Court Fulton, MD 20759 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-15 |
| Decision Date | 2022-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10070907000790 | K213921 | 000 |
| 18859798101302 | K213921 | 000 |
| 18859798101296 | K213921 | 000 |
| 18859798101272 | K213921 | 000 |
| 18859798101258 | K213921 | 000 |
| 18859798101241 | K213921 | 000 |
| 18859798101203 | K213921 | 000 |
| 18859798101548 | K213921 | 000 |
| 18859798101531 | K213921 | 000 |
| 18859798101524 | K213921 | 000 |
| 18859798101517 | K213921 | 000 |
| 18859798101333 | K213921 | 000 |
| 18859798101098 | K213921 | 000 |
| 18859798101104 | K213921 | 000 |
| 10070907000783 | K213921 | 000 |
| 10070907000820 | K213921 | 000 |
| 10070907000806 | K213921 | 000 |
| 18859798100305 | K213921 | 000 |
| 18859798100299 | K213921 | 000 |
| 18859798101173 | K213921 | 000 |
| 18859798101166 | K213921 | 000 |
| 18859798101142 | K213921 | 000 |
| 18859798101128 | K213921 | 000 |
| 18859798101111 | K213921 | 000 |
| 18859798101647 | K213921 | 000 |