The following data is part of a premarket notification filed by Metacure Surgical Gloves Sdn Bhd with the FDA for Powder-free Latex Examination Gloves - 18 Mils At Finger, Blue Color; 9 And 10 Mils At Finger, Natural Color.
| Device ID | K072197 |
| 510k Number | K072197 |
| Device Name: | POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR |
| Classification | Patient Examination Glove, Specialty |
| Applicant | METACURE SURGICAL GLOVES SDN BHD NO. 1, JLN 203, OFF JALAN TANDANG Petaling Jaya, MY 46050 |
| Contact | Azman Ismail |
| Correspondent | Azman Ismail METACURE SURGICAL GLOVES SDN BHD NO. 1, JLN 203, OFF JALAN TANDANG Petaling Jaya, MY 46050 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-07 |
| Decision Date | 2008-03-12 |