The following data is part of a premarket notification filed by Matang Mfg. Sdn. Bhd. with the FDA for Matang Powder-free Low Protein Latex Patient Examination Glove.
| Device ID | K982877 |
| 510k Number | K982877 |
| Device Name: | MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE |
| 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 | Ronald Leong |
| Correspondent | Ronald Leong 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 | 1998-08-14 |
| Decision Date | 1998-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30851253007947 | K982877 | 000 |
| 30851253007930 | K982877 | 000 |
| 30851253007923 | K982877 | 000 |
| 30851253007954 | K982877 | 000 |