The following data is part of a premarket notification filed by Shamrock Manufacturing Company with the FDA for Powder Free Synthetic Nitrile Neoprene Examination Gloves, Sizes Small,medium, Large, And X-large.
| Device ID | K030386 |
| 510k Number | K030386 |
| Device Name: | POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE |
| Classification | Polymer Patient Examination Glove |
| Applicant | SHAMROCK MANUFACTURING COMPANY 5445 DANIELS ST. Chino, CA 91710 |
| Contact | Emmy Tjoeng |
| Correspondent | Emmy Tjoeng SHAMROCK MANUFACTURING COMPANY 5445 DANIELS ST. Chino, CA 91710 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-05 |
| Decision Date | 2003-03-28 |
| Summary: | summary |