The following data is part of a premarket notification filed by Latexx Manufacturing Sdn.bhd. with the FDA for Latexx Manufacturing Non-chlorinated, Polymer Coated, Powder-free Rubber Latex Examination Glove.
| Device ID | K014087 |
| 510k Number | K014087 |
| Device Name: | LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | LATEXX MANUFACTURING SDN.BHD. P.O. BOX 4341 Crofton, MD 21114 |
| Contact | Yolanda Smith |
| Correspondent | Yolanda Smith LATEXX MANUFACTURING SDN.BHD. P.O. BOX 4341 Crofton, MD 21114 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-11 |
| Decision Date | 2002-03-04 |