The following data is part of a premarket notification filed by Top Calibre Sdn Bhd with the FDA for Latex Examination Gloves (powder Free).
| Device ID | K120692 |
| 510k Number | K120692 |
| Device Name: | LATEX EXAMINATION GLOVES (POWDER FREE) |
| Classification | Latex Patient Examination Glove |
| Applicant | TOP CALIBRE SDN BHD 1-1,2 JALAN SETIA PRIMA U13/S SETIA ALAM, SEKSYEN U13 Shah Alam, 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, 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 | 2012-03-07 |
| Decision Date | 2012-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60818634020088 | K120692 | 000 |
| 40818634020114 | K120692 | 000 |
| 40818634020107 | K120692 | 000 |
| 40818634020077 | K120692 | 000 |
| 40818634020091 | K120692 | 000 |