The following data is part of a premarket notification filed by Pt. Intan Hevea Industry with the FDA for Skin Guard, Powder Free Latex Examination Gloves, Non-sterile.
| Device ID | K111923 |
| 510k Number | K111923 |
| Device Name: | SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. INTAN HEVEA INDUSTRY JL. PULAU IRIAN (KAWASAN IND. MEDAN), JL. KOM LAUT YOS Sudarso Km. 10,5, Medan, ID 20242 |
| Contact | Darwin Tandjo |
| Correspondent | Darwin Tandjo PT. INTAN HEVEA INDUSTRY JL. PULAU IRIAN (KAWASAN IND. MEDAN), JL. KOM LAUT YOS Sudarso Km. 10,5, Medan, ID 20242 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-07 |
| Decision Date | 2011-11-04 |
| Summary: | summary |