The following data is part of a premarket notification filed by Pt. Shamrock Manufacturing Corp. with the FDA for Latex Examination Gloves- Powder Free, Blue.
| Device ID | K011712 |
| 510k Number | K011712 |
| Device Name: | LATEX EXAMINATION GLOVES- POWDER FREE, BLUE |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. SHAMROCK MANUFACTURING CORP. 889 SOUTH AZUSA AVE. City Of Industry, CA 91748 |
| Contact | Emmy Tjoeng |
| Correspondent | Emmy Tjoeng PT. SHAMROCK MANUFACTURING CORP. 889 SOUTH AZUSA AVE. City Of Industry, CA 91748 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-04 |
| Decision Date | 2001-07-17 |
| Summary: | summary |