The following data is part of a premarket notification filed by Latexx Manufacturing Sdn.bhd. with the FDA for Powder Free Nitrle Examination Gloves With Chemotherapy Labeling Claim.
| Device ID | K102189 |
| 510k Number | K102189 |
| Device Name: | POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM |
| Classification | Patient Examination Glove, Specialty |
| Applicant | LATEXX MANUFACTURING SDN.BHD. 11925 W 1-70 FRONTAGE RD NORTH, SUITE 900 Wheat Ridge, CO 80033 |
| Contact | Neil Burris |
| Correspondent | Neil Burris LATEXX MANUFACTURING SDN.BHD. 11925 W 1-70 FRONTAGE RD NORTH, SUITE 900 Wheat Ridge, CO 80033 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-02 |
| Decision Date | 2012-03-14 |
| Summary: | summary |