The following data is part of a premarket notification filed by Perusahaan Getah Asas Sdn Bhd with the FDA for On-line Powder-free Latex Examination Glove, Type Ii,low Modulus, With Protein Labeling Claim.
| Device ID | K030331 |
| 510k Number | K030331 |
| Device Name: | ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM |
| Classification | Latex Patient Examination Glove |
| Applicant | PERUSAHAAN GETAH ASAS SDN BHD 1301 DEFENSE HIGHWAY Gambrills, MD 21054 -1928 |
| Contact | James F Logan |
| Correspondent | James F Logan PERUSAHAAN GETAH ASAS SDN BHD 1301 DEFENSE HIGHWAY Gambrills, MD 21054 -1928 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-31 |
| Decision Date | 2003-03-21 |