The following data is part of a premarket notification filed by Kossan Latex Industries (m) Sdn. Bhd. with the FDA for Laxtex Powdered Examination Glove With Protein Labeling Claim (100 Micrograms Or Less).
| Device ID | K001557 |
| 510k Number | K001557 |
| Device Name: | LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LOT 16632, 5-1/4 MILES, JALAN MERU Kelang, Selangor, MY 41050 |
| Contact | Lim Kwan Hwa |
| Correspondent | Lim Kwan Hwa KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LOT 16632, 5-1/4 MILES, JALAN MERU Kelang, Selangor, MY 41050 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-19 |
| Decision Date | 2000-06-09 |