The following data is part of a premarket notification filed by Wear Safe (malaysia) Sdn. Bhd. with the FDA for Powder Free Polymer Coated Latex Examination Gloves, Non-sterile, With Protein Labeling Claim Of 50 Micrograms Per Dm2 O.
| Device ID | K092492 |
| 510k Number | K092492 |
| Device Name: | POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O |
| 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 | 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-13 |
| Decision Date | 2009-10-21 |
| Summary: | summary |