The following data is part of a premarket notification filed by Pt. Abbergummi Medical with the FDA for Powder Free Latex Examination Gloves.
| Device ID | K931521 |
| 510k Number | K931521 |
| Device Name: | POWDER FREE LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. ABBERGUMMI MEDICAL KOMPLEK DELTA SARI INDAH, BLOK AA/4 Waru.sidoarjo, ID 61256 |
| Contact | Tong K. |
| Correspondent | Tong K. PT. ABBERGUMMI MEDICAL KOMPLEK DELTA SARI INDAH, BLOK AA/4 Waru.sidoarjo, ID 61256 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-26 |
| Decision Date | 1994-01-13 |