The following data is part of a premarket notification filed by Sempermed Usa, Inc. with the FDA for Latex Powdered Patient Examination Glove, 200 Micrograms Or Less.
| Device ID | K011749 |
| 510k Number | K011749 |
| Device Name: | LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS |
| Classification | Latex Patient Examination Glove |
| Applicant | SEMPERMED USA, INC. 30798 US HWY. 19 NORTH Palm Harbor, FL 34684 |
| Contact | Katie Levinson |
| Correspondent | Katie Levinson SEMPERMED USA, INC. 30798 US HWY. 19 NORTH Palm Harbor, FL 34684 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-31 |
| Decision Date | 2001-08-22 |
| Summary: | summary |