The following data is part of a premarket notification filed by P.t. Maja Agung Latexindo with the FDA for Powder Free Latex Examination Glove With Protein Content Labeling Claim (50 Micrograms Or Less).
| Device ID | K982897 |
| 510k Number | K982897 |
| Device Name: | POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | P.T. MAJA AGUNG LATEXINDO 345 CLOVERLEAF DRIVE, SUITE B Baldwin Park, CA 91706 |
| Contact | Emmy Tjoeng |
| Correspondent | Emmy Tjoeng P.T. MAJA AGUNG LATEXINDO 345 CLOVERLEAF DRIVE, SUITE B Baldwin Park, CA 91706 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-17 |
| Decision Date | 1998-12-23 |
| Summary: | summary |