The following data is part of a premarket notification filed by Quality Latex Corp. Sdn Bhd with the FDA for Quality Latex Powdered Latex Medical Gloves With Protein Content Labeling Claim Of 170 Microgram Or Less.
| Device ID | K993271 |
| 510k Number | K993271 |
| Device Name: | QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 170 MICROGRAM OR LESS |
| Classification | Latex Patient Examination Glove |
| Applicant | QUALITY LATEX CORP. SDN BHD 18-20, JALAN KILANG 2, JELANPANG LIGHT INDUST. ESTATE Ipoh, Perak, MY 30100 |
| Contact | Sharene Wan |
| Correspondent | Sharene Wan QUALITY LATEX CORP. SDN BHD 18-20, JALAN KILANG 2, JELANPANG 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 | 1999-09-30 |
| Decision Date | 1999-12-02 |