The following data is part of a premarket notification filed by Wear Safe (malaysia) Sdn. Bhd. with the FDA for Powder Free Latex Examination Gloves Blue (colored), Non-sterile, With Protein Labeling Claim Of 50ug Per Dm2 Of Glove.
| Device ID | K101799 |
| 510k Number | K101799 |
| Device Name: | POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | WEAR SAFE (MALAYSIA) SDN. BHD. LOT PT 13726,JALAN HAJI SALLEH OFF JALAN MERU Klang, Selangor Darul Ehsan, MY 41050 |
| Contact | Mohd Azlan |
| Correspondent | Mohd Azlan WEAR SAFE (MALAYSIA) SDN. BHD. LOT PT 13726,JALAN HAJI SALLEH OFF JALAN MERU Klang, Selangor Darul Ehsan, MY 41050 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-28 |
| Decision Date | 2010-09-03 |
| Summary: | summary |