The following data is part of a premarket notification filed by Kossan Latex Industries (m) Sdn. Bhd. with the FDA for Low Protein Latex Examination Gloves.
| Device ID | K970222 |
| 510k Number | K970222 |
| Device Name: | LOW PROTEIN LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LOT 16632, 5-1/4 MILES, JALAN MERU Kelang, Selangor, MY 41050 |
| Contact | Lim Kuang Sia |
| Correspondent | Lim Kuang Sia KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LOT 16632, 5-1/4 MILES, JALAN MERU Kelang, Selangor, MY 41050 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-21 |
| Decision Date | 1997-06-24 |