The following data is part of a premarket notification filed by Matang Mfg. Sdn. Bhd. with the FDA for Latex Examination Gloves.
| Device ID | K896094 |
| 510k Number | K896094 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | MATANG MFG. SDN. BHD. 83-A, JALAN LANGKASUKA, LARKIN INDUSTRIAL AREA, 80350 JOHOR Bahru Johor Darul Takzim, MY |
| Contact | Krishnan Sabapathy |
| Correspondent | Krishnan Sabapathy MATANG MFG. SDN. BHD. 83-A, JALAN LANGKASUKA, LARKIN INDUSTRIAL AREA, 80350 JOHOR Bahru Johor Darul Takzim, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-20 |
| Decision Date | 1990-01-17 |