The following data is part of a premarket notification filed by Latexx Manufacturing Sdn.bhd. with the FDA for Non-chlorinated, Polymer Coated Powder Free Natural Rubber Latex Examination Gloves And Protein Labeling Claim Of.
| Device ID | K101645 |
| 510k Number | K101645 |
| Device Name: | NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF |
| Classification | Latex Patient Examination Glove |
| Applicant | LATEXX MANUFACTURING SDN.BHD. PT. 5054, KAMUNTING INDUSTRIAL ESTATE Taiping, Perak, MY 34600 |
| Contact | Terence Lim Sin Kooi |
| Correspondent | Terence Lim Sin Kooi LATEXX MANUFACTURING SDN.BHD. PT. 5054, KAMUNTING INDUSTRIAL ESTATE Taiping, Perak, MY 34600 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-11 |
| Decision Date | 2010-08-26 |
| Summary: | summary |