The following data is part of a premarket notification filed by Pt. Smart Glove Indonesia with the FDA for Powder Free Green, Blue And Brown Polychloroprene Examination Gloves.
| Device ID | K133699 |
| 510k Number | K133699 |
| Device Name: | POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | PT. SMART GLOVE INDONESIA JL. PELITA RAUYA NO. 5-7,KIM STAR, TANJUNG MORAWA Medan, North Sumater, ID 20362 |
| Contact | Khon Pu Foo |
| Correspondent | Khon Pu Foo PT. SMART GLOVE INDONESIA JL. PELITA RAUYA NO. 5-7,KIM STAR, TANJUNG MORAWA Medan, North Sumater, ID 20362 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-03 |
| Decision Date | 2014-07-18 |
| Summary: | summary |