The following data is part of a premarket notification filed by Comfort Rubber Gloves Industries Sdn Bhd with the FDA for Comfort Latex Powdered Patient Examination Gloves With Protein Label Claim Contains 200 Micrograms Or Less Of Total Wate.
| Device ID | K001042 |
| 510k Number | K001042 |
| Device Name: | COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE |
| Classification | Latex Patient Examination Glove |
| Applicant | COMFORT RUBBER GLOVES INDUSTRIES SDN BHD LOT 821, JALAN MATANG Taiping, Perak Darul Ridzuan, MY 34750 |
| Contact | Chee Yong Foo |
| Correspondent | Chee Yong 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 | 2000-03-31 |
| Decision Date | 2000-05-23 |