The following data is part of a premarket notification filed by Medtexx Manufacturing Sdn. Bhd. with the FDA for Powdered Natural Rubber Latex Examination Gloves (protein Label Claim) 200 Micrograms Or Less Of Total Water Extractable.
| Device ID | K070821 |
| 510k Number | K070821 |
| Device Name: | POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE |
| Classification | Latex Patient Examination Glove |
| Applicant | MEDTEXX MANUFACTURING SDN. BHD. PT 4004 KAMUNTING INDU. ESTATE Kamunting, Taiping, Perak, MY 34600 |
| Contact | Ooi Loon Seng |
| Correspondent | Ooi Loon Seng MEDTEXX MANUFACTURING SDN. BHD. PT 4004 KAMUNTING INDU. ESTATE Kamunting, 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 | 2007-03-26 |
| Decision Date | 2007-05-10 |
| Summary: | summary |