The following data is part of a premarket notification filed by Pt. Shamrock Manufacturing Corp. with the FDA for Powder Free Nitrile Examination Gloves, Blue.
| Device ID | K052382 |
| 510k Number | K052382 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE |
| Classification | Polymer Patient Examination Glove |
| Applicant | PT. SHAMROCK MANUFACTURING CORP. 5445 DANIELS STREET Chino, CA 91710 |
| Contact | Emmy Tjoeng |
| Correspondent | Emmy Tjoeng PT. SHAMROCK MANUFACTURING CORP. 5445 DANIELS STREET 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 | 2005-08-30 |
| Decision Date | 2005-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10641932303554 | K052382 | 000 |
| 00641932303120 | K052382 | 000 |
| 00641932303137 | K052382 | 000 |
| 00641932303144 | K052382 | 000 |
| 10641932303509 | K052382 | 000 |
| 10641932303516 | K052382 | 000 |
| 10641932303523 | K052382 | 000 |
| 10641932303530 | K052382 | 000 |
| 10641932303547 | K052382 | 000 |
| 00641932303113 | K052382 | 000 |