The following data is part of a premarket notification filed by Pt. Berlian Glovindo with the FDA for Nitrile Examination Gloves- Pre-powdered, Small, Medium, And Large.
| Device ID | K992177 |
| 510k Number | K992177 |
| Device Name: | NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE |
| Classification | Polymer Patient Examination Glove |
| Applicant | PT. BERLIAN GLOVINDO JLN. RAYA MEDAN RANTAU PRAPAT KM +230 DESA DAMULI Kec. Labuhan Batu - N. Sumatra, ID |
| Contact | Tony Jap |
| Correspondent | Tony Jap PT. BERLIAN GLOVINDO JLN. RAYA MEDAN RANTAU PRAPAT KM +230 DESA DAMULI Kec. Labuhan Batu - N. Sumatra, ID |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-28 |
| Decision Date | 1999-07-29 |
| Summary: | summary |