The following data is part of a premarket notification filed by Wear Safe Malaysia Sdn. Bhd. with the FDA for Sterile And Non-sterile Powder-free Latex Patient Examination Glove, With Extractable Protein Content Labeling Claim (50.
| Device ID | K062917 |
| 510k Number | K062917 |
| Device Name: | STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50 |
| Classification | Latex Patient Examination Glove |
| Applicant | WEAR SAFE MALAYSIA SDN. BHD. LOT 1, LEBOH HISHAMUDDIN SATU, NORTH KLANG STRAITS IND. AREA Port Klang, Selangor, D.e., MY 42000 |
| Contact | Tk Loh |
| Correspondent | Tk Loh WEAR SAFE MALAYSIA SDN. BHD. LOT 1, LEBOH HISHAMUDDIN SATU, NORTH KLANG STRAITS IND. AREA Port Klang, Selangor, D.e., MY 42000 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-28 |
| Decision Date | 2006-11-02 |