The following data is part of a premarket notification filed by Comfort Rubber Gloves Industries Sdn Bhd with the FDA for Patient Latex Polymer Coated Powder-free Gloves, Contains 50 Microgram Or Less Of Total Water Extractable Protein Per Gr.
| Device ID | K002065 |
| 510k Number | K002065 |
| Device Name: | PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR |
| Classification | Latex Patient Examination Glove |
| Applicant | COMFORT RUBBER GLOVES INDUSTRIES SDN BHD LOT 821, JALAN MATANG Taiping, Perak Darul Ridzuan, MY 34750 |
| Contact | Chee Y Foo |
| Correspondent | Chee Y Foo COMFORT RUBBER GLOVES INDUSTRIES SDN BHD LOT 821, JALAN MATANG Taiping, Perak Darul Ridzuan, MY 34750 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-07 |
| Decision Date | 2000-08-22 |