The following data is part of a premarket notification filed by Pt. Shamrock Manufacturing Corp. with the FDA for Powdered Latex Examination Gloves, Small, Medium, Large, X-large.
| Device ID | K081040 |
| 510k Number | K081040 |
| Device Name: | POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE |
| 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 | 2008-04-11 |
| Decision Date | 2008-05-20 |