The following data is part of a premarket notification filed by Wear Safe (malaysia) Sdn Bhd - Facility Ii with the FDA for Powder Free Nitrile Patient Examination Glove, Blue And White Colored, Non-sterile.
| Device ID | K123469 |
| 510k Number | K123469 |
| Device Name: | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE |
| Classification | Polymer Patient Examination Glove |
| Applicant | WEAR SAFE (MALAYSIA) SDN BHD - FACILITY II LOT 63616, PT 54924, NO 3, JALAN KORPORAT 7C/KU9 TAMAN PERINDUSTRIAN MERU Mukim Kapar, Klang, Selangor, MY 42200 |
| Contact | Alex Yoong |
| Correspondent | Alex Yoong WEAR SAFE (MALAYSIA) SDN BHD - FACILITY II LOT 63616, PT 54924, NO 3, JALAN KORPORAT 7C/KU9 TAMAN PERINDUSTRIAN MERU Mukim Kapar, Klang, Selangor, MY 42200 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-13 |
| Decision Date | 2013-02-19 |
| Summary: | summary |