The following data is part of a premarket notification filed by Wear Safe Malaysia Sdn. Bhd. with the FDA for Patient Examination Powder-free Gloves.
| Device ID | K973020 |
| 510k Number | K973020 |
| Device Name: | PATIENT EXAMINATION POWDER-FREE GLOVES |
| 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 | Claude Cottet |
| Correspondent | Claude Cottet 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 | 1997-08-13 |
| Decision Date | 1998-01-06 |