The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn. Bhd. with the FDA for Non-sterile Powder-free Latex Examination Gloves Colored.
| Device ID | K974518 |
| 510k Number | K974518 |
| Device Name: | NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED |
| Classification | Latex Patient Examination Glove |
| Applicant | YTY INDUSTRY (MANJUNG) SDN. BHD. LOT 2935B KG BATU 9 KEBUN BARU JALAN MASJID TELOK PANGLIMA Kuala Langat Selangor D.e., MY 42500 |
| Contact | Leonard Frier |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1997-12-02 |
| Decision Date | 1997-12-12 |
| Summary: | summary |