The following data is part of a premarket notification filed by Quality Latex Products Malaysia Sdn Bhd with the FDA for Polymer Coated Latex Medical Examination Gloves With Protein Content Labeling Claim (50 Micrograms Or Less).
| Device ID | K011995 |
| 510k Number | K011995 |
| Device Name: | POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | QUALITY LATEX PRODUCTS MALAYSIA SDN BHD 18-20, JALAN KILANG 2 JELAPANG LIGHT INDUST. ESTATE Ipoh. Perak, MY 30100 |
| Contact | Sharene Wan |
| Correspondent | Sharene Wan QUALITY LATEX PRODUCTS MALAYSIA SDN BHD 18-20, JALAN KILANG 2 JELAPANG LIGHT INDUST. ESTATE Ipoh. Perak, MY 30100 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-26 |
| Decision Date | 2001-07-31 |