The following data is part of a premarket notification filed by Pt. Shamrock Manufacturing Corp. with the FDA for Powderfree Latex Examination Gloves With Bubblegum.
| Device ID | K030325 |
| 510k Number | K030325 |
| Device Name: | POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. SHAMROCK MANUFACTURING CORP. 5445 DANIELS ST. Chino, CA 91710 |
| Contact | Emmy Tjoeng |
| Correspondent | Emmy Tjoeng PT. SHAMROCK MANUFACTURING CORP. 5445 DANIELS ST. Chino, CA 91710 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-31 |
| Decision Date | 2003-03-28 |
| Summary: | summary |