The following data is part of a premarket notification filed by Top Calibre Sdn Bhd with the FDA for Powder Free Latex Patient Examination Glove, With Protein Content Labeling Claim.
| Device ID | K112612 |
| 510k Number | K112612 |
| Device Name: | POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM |
| Classification | Latex Patient Examination Glove |
| Applicant | TOP CALIBRE SDN BHD 1-1,2 JALAN SETIA PRIMA U13/S SETIA ALAM, SEKSYEN U13 Shah Alam, Selangor, MY 40170 |
| Contact | Tracy Ngui |
| Correspondent | Tracy Ngui TOP CALIBRE SDN BHD 1-1,2 JALAN SETIA PRIMA U13/S SETIA ALAM, SEKSYEN U13 Shah Alam, Selangor, MY 40170 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-07 |
| Decision Date | 2012-01-18 |
| Summary: | summary |