The following data is part of a premarket notification filed by Amercare, Inc. with the FDA for C2 Medical Gloves.
| Device ID | K113639 |
| 510k Number | K113639 |
| Device Name: | C2 MEDICAL GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | AMERCARE, INC. 611 W. 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Contact | Andrew Lowery |
| Correspondent | Andrew Lowery AMERCARE, INC. 611 W. 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-09 |
| Decision Date | 2012-05-08 |
| Summary: | summary |