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, Sterile, With Protein Labeling Claim Of 50 Ug Per Dm2 Of Glove.
| Device ID | K090327 |
| 510k Number | K090327 |
| Device Name: | POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | WEAR SAFE (MALAYSIA) SDN. BHD. LOT PT 13726,JALAN HAJI SALLEH BATU 5 1/4 OFF JALAN MERU Klang, Selangor, MY 41050 |
| Contact | S.h. Tan |
| Correspondent | S.h. Tan WEAR SAFE (MALAYSIA) SDN. BHD. LOT PT 13726,JALAN HAJI SALLEH BATU 5 1/4 OFF JALAN MERU Klang, Selangor, 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 | 2009-02-09 |
| Decision Date | 2009-04-03 |
| Summary: | summary |