The following data is part of a premarket notification filed by Wear Safe (malaysia) Sdn. Bhd. with the FDA for Powder Free Nitrile Examination Gloves, White (non-colored) Or Blue (colored), Non-sterile.
| Device ID | K093500 |
| 510k Number | K093500 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE |
| Classification | Patient Examination Glove, Specialty |
| Applicant | WEAR SAFE (MALAYSIA) SDN. BHD. LOT PT 13726,JALAN HAJI SALLEH OFF JALAN MERU Klang, Selangor Darul Ehsan, MY 41050 |
| Contact | S.h. Tan |
| Correspondent | S.h. Tan WEAR SAFE (MALAYSIA) SDN. BHD. LOT PT 13726,JALAN HAJI SALLEH OFF JALAN MERU Klang, Selangor Darul Ehsan, MY 41050 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-12 |
| Decision Date | 2010-01-19 |
| Summary: | summary |